Jobs That Crossed My Desk Through Aug
Jobs That Crossed My Desk Through April 26, 2015 Complimentary Service of Audreysnetwork.com April 26, 2015 If interested in a listed position, contact the person whose information appears at the top of each listing. Individual listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines. Remember I’m not a recruiter and only distribute this listing to help bioscience industry professionals identify potential positions with contact person information provided where possible. These positions originated with individuals in my network. Note that recently I’ve begun to receive many listings via Linked In and in such cases, I’ve listed company website if not person who sent listing to me. Jobs are materializing but with such a large pool of qualified professionals at this time, they fill up fast. Always be sure to check the website of recruiter or company to learn what jobs have popped up in between my publications. Unfortunately, I’m not able to post these every day but this tip should help you find newly posted jobs from the contacts sending the jobs below. Be sure to join the Bio2Device Group (includes professionals from all life science sectors and functions) to access their list of positions which includes different universe of jobs. You must attend one of B2DG meetings to become member but application in free. See details at www.bio2devicegroup.org. Next BioSpace Career Fair in Bay Area scheduled for Oct. 28, 2015. See details at http://www.biospace.com/jobs/career-fair/ *************************************************************************** Please see below opportunities and send resume as an attachment to wd_darshana at hotmail dot. My imminent openings are for Senior Electrical, Mechanical, Quality and Software Engineering – all with strong medical device experience. Please also notice contract opportunities at the end. All US opportunities are for US based and local candidates. When sending a resume, please mention job you are interested in, in the subject line and in the email include a brief summary of how best the job description matches your background and where the gaps are. This is a photo symbolizing the job search in today’s economy. Out of the darkness, there seems to be a ray of hope–but where? (Photo credit: Wikipedia) Director of Mechanical Engineering – San Jose, CA Requires 20+ years experience in polymers, balloons manufacturing. Complete details will be posted soon. Mechanical Engineer – San Jose, CA Requires 5+ years medical device experience. Details will be posted soon. Quality Engineer – San Jose, CA Requires BS in Engineering and 10+ years medical device QE experience. Details coming soon. Physiologist – San Jose, CA Requires large animals survival surgery experience. Details coming soon. Biochemist – San Jose, CA Requires PhD + 3-5 years industry experience. Details will be posted soon. Ruby on Rails Engineer – San Mateo, CA Senior Electrical Engineer – Austin/ San Antonio – TX A company working on innovative range of products, has an immediate opening for senior electrical engineer with class III device experience. Experience with closed loop, analog design hardware, microcontrollers, actuators and ultra low power consumption circuit design highly desired. Key Responsibilities * Lead Electrical Engineering, primarily for long-term implantable drug delivery devices: * on R&D- design and development of implantable and associated wearable and external hardware using mixed signal- analog and digital techniques, sensors and actuators and closed-loop control systems * Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation esp for implantable electronics * Develop Class III implantable electronics to be compliant with regulatory and QA standards (FDA and ISO), as well as be power-efficient, reliable for multi-year operation and pass EMI/RFI, be hermetically sealed and packaged and interface with rest of electronics systems for developed products * Establish reliable suppliers and partners for manufacturing 4/26/2015 1 * Work in a matrixed and multidisciplinary organizational structure to support multiple projects and technologies following appropriate QA system for each segment * Document work output and use project and organizational documentation systems, including electronic systems * Plan for and support existing and projected growth of the company. Key Qualifications * Designed and implemented electronics mixed-signal hardware, firmware and software for implantable medical devices and drugs. Combinatorial device and Class III experience desirable. 10-15 15 years desirable * Bachelor’s degree in Electrical Engineering or in an equivalent field required * Led and grown EE groups with a hands-on, leadership- by-example approach * Demonstrated working experience and accomplishments with electronics hardware and softwareanalog/digital, sensors/actuators. Developed, selected and qualified sensors for both implantable device function and for measuring physiological parameters * Familiarity and experience with other implantable device components such as connectors, leads, cables, interconnects, headers, electronics packaging, communication protocols and standards. Real-time microcontroller programming a plus. * Excellent and demonstrated grasp and use EDA tools: sensor/circuit design, simulation, layout. Hands on re: circuit and system prototyping and development * Developed and implemented manufacturability, and related process flows and controls. Selected and qualified vendors for manufacturing Class III implantable device electronics. * Working knowledge of biomaterials, drugs, drug delivery, and mechanical technologies in support of multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business. * Strong technical and hands-on skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity * Analytical data-driven problem solver and team player, organized and an excellent communicator * Supported multiple complex projects in a start-up environment: able to prioritize. Key Job Parameters * Full-time position located near Austin/ San Antonio, Texas * Some travel (~10%) may be necessary to meet job responsibilities * Report to VP, Product Development Senior Design Engineer with Embedded Hardware & Firmware Skills – Santa Clara, CA A reputed contract engineering company has an immediate full time opportunity for a Senior Design Engineer with Embedded Hardware & Firmware Skills. A rounded individual is desired who has an interest and ability in a wide range of technologies. The successful candidate will lead a group of engineers from time-to-time and may be required to act as the primary interface to the customers at times. The company designs devices, firmware, and software for other companies and has a reputation for quick response with high quality work. The person must enjoy working with customers and have good communication skills. The person must work well on a team of high performing engineers. The person needs to be organized. The person must work well with others and be flexible as schedules and priorities change. Technical requirements: Ten years of experience in embedded system design engineering is required. Ability to supervise others is highly desired. The person should have experience designing circuits with microprocessors from PIC to ARM, FPGAs, Bluetooth, and WiFi as well as experience with programming in C or C++ on these devices. The person must enjoy learning and be able to learn quickly. The ability to design and program FPGAs is desired. This could be a work-at-home job, or work at the company site, in Santa Clara, CA. QUALITY ENGINEER – Santa Cruz, CA See full description in March Job posting. Senior Quality Engineer – Austin/ San Antonio – TX A company working on innovative drug delivery technology has an immediate opening for senior quality engineer. Great opportunity to work at grounds level and grow into leadership role, in addition to the upside of stocks. Key Responsibilities: * Lead QA for: R&D- design, development, V&V phases including hazard/risk analysis and mitigation, DOE and related statistical design and analyses, GDT, design reviews, audits/compliance; Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, 4/26/2015 2 sterilization and packaging development and validation * Develop and implement QA systems to be compliant with applicable international and national standards such as ISO 13485 and regulatory requirements of FDA CFR 820 and other bodies for Class III implantables * Implement productive relationships with R&D and manufacturing suppliers and partners * Work in a matrixed organizational structure to support company’s facilities, including the respective incubated companies, projects and technologies with an appropriate QA system for each segment * Educate colleagues and support in-house uptake & implementation of these systems organizationwide* Support the following functions: Regulatory Affairs: provide appropriate documentation and materials to support filings for US and international trials and approvals; Intellectual Property: supporting documentation; Business and Commercialization, including due diligence documentation * Develop & implement documentation systems for these business functions, including electronic systems, with help of to –be-hired Documentation Specialist Key Qualifications * Designed and implemented QA systems for implantable medical devices and drugs. Combinatorial device and Class III experience desirable. At least 10 years experience, >15 years desirable* * Bachelor’s degree in Engineering or in an equivalent field required, with ASQ certification (CQE, CRE, CQM, CSSBB) desirable * Led and grown QA organizations with a hands-on, leadership- by-example approach * Demonstrated working experience with electronics hardware and software, biomaterials, drugs, drug delivery, and mechanical technologies while supporting multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business. * Excellent and demonstrated grasp and use of statistics in R&D and manufacturing including DOE * Supported multiple complex projects and start-ups: able to prioritize. * Developed and implemented design controls, documentation, and design procedures, protocols * Developed and implemented manufacturability, and related process flows and controls, and selected qualified vendors to manufacture Class III implantable devices * Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity * Analytical data-driven problem solver and team player, organized and an excellent communicator Key Job Parameters * Full-time position located in Austin/ San Antonio, Texas * Some travel (~10%) may be necessary to meet job responsibilities * Report to VP, Product Development Contract Opportunities with skills in following areas – San Jose, CA * Electrical Engineering & Software * Analog Design * PCB Layout (FR4, Flex etc.) * ASIC Design * Embedded Systems * TI MSP430, ARM, Cypress * Software (Windows, Linux, C++, Android, iOS) * Sensors * RF Communications * Bluetooth, Wi-Fi, 3G, 4G, GPS * Antenna Design * RF Test Labs * Test Engineering * Test Hardware & Software * Manufacturing Engineering * Fixture Design * DFM, DFT (Design for manufacturing, Design for Testability) * Process Development * Machine Shop Support ************************************************************************************ * [email protected] 4/26/2015 3 APPLY FOR THIS JOB Contact Person: Maria Pell Email Address: [email protected] Apply URL: https://careers-prothena.icims.com/jobs/1030/head-... Head of Communications Job ID: 23321319 Position Title: Head of Communications Posted: April 16, 2015 Company Name: Prothena Job Type: Full-Time Industry: Biotechnology Job Duration: Indefinite Job Function: Communications Min Education: BA/BS/Undergraduate Entry Level: No Location(s): South San Francisco, California, 94080, United States Min Experience: Over 10 Years Required Travel: None APPLY FOR THIS JOB Contact Person: Maria Pell Email Address: [email protected] Apply URL: https://careers-prothena.icims.com/jobs/1030/head-... Save Job Email Job Pri Job Description Responsibilities: The Head of Communications will: Provide strategic leadership, development, direction and management of all Prothena corporate communications and public relations initiatives, while partnering closely with: the Chief Financial Officer to coordinate investor meetings/communications, and the Head of Clinical Affairs to coordinate scientific communications (publications and scientific conference participation), patient outreach/advocacy and government relations initiatives. Develop and manage all communications – examples include: internal and external collateral/publications, executive presentations and speechwriting, webcasts, industry and financial press releases, on-line/electronic communications, quarterly earnings announcements, annual report and web content. Advise and work closely with the CEO, CFO, CSO / Head of R&D – as well as other key corporate and scientific leadership team members – on executive communications/presentations to ensure clear consistent messages are being delivered to the internal (employees, board, etc.) and external (investors, patients, KOLs, etc.) audiences. Communicate Prothena’s primary objectives, strategies, pipelines, operations and financials, as well as be the primary liaison and contact person for the media and investment community. Coordinate meetings on behalf of leadership/management with new and existing investors, research analysts, investment banks, and media. Build and maintain relationships with the various stakeholders that influence the Company’s success – including the investor, research analyst, investment banks and media, patient advocacy and government affairs. Job Requirements Qualifications: Ideal candidate will have a minimum of 10-15 years of investor and corporate communications experience in a corporate or agency setting with responsibility for the strategic direction of such programs. Biotechnology/biopharmaceutical, pharmaceutical, life sciences or related industry as well as previous experience communicating similar business models to external audiences is required. In addition, the successful candidate: 4/26/2015 4 Must have demonstrated leadership skills and a successful track record with establishing relationships within a company and with investment banks, research analysts and the investor communities. Must be results oriented with tenacity to drive efforts from concept to development to implementation. High energy, adaptability and integrity. Self-starter with high standards of performance. Must have strong strategic thinking skills and the ability to develop and execute investor and corporate communications programs. Must be able to budget and manage internal/external resources. Must have exceptional communication, presentation and interpersonal skills with all levels in the organization. Must be a strong manager and proven leader who works with the highest level of ethical and professional values in a matrixed environment. Must be able to partner with the Chief Accounting Officer and Head of Finance in managing the Company’s financial communications, including quarterly earnings preparation and scripts, media outreach, annual report, and leadership content for investor presentations. Should have financial and analytical skills with demonstrated ability to interpret information for the investment community and senior management. Must possess excellent oral and written communications skills and have the ability to work independently in a fast-paced and fast-tracked environment. Ability to translate scientific concepts into language for the lay public. Candidate should have excellent computer-based skills and presentation skills. Candidate should be able to manage agencies, vendors and budgets for delivery of on-time and onbudget deliverables. Must be an analytical thinker and decision maker, especially on complex issues, as well as problem solver with practical and sensible solutions. Preferred Education, Experience and Skills Must have BA/BS. Marketing, Communications, Journalism, Business Administration or related area (Science degree a plus); MBA a plus. Traditional and Social media experience. Personal Competencies Candidate will possess maturity, experience and help shape, build, maintain and protect the Company’s image and reputation and provide its leaders with confidence in his/her abilities and business judgment. Candidate will act with urgency in order to achieve results while maintaining high quality standards and attention to detail. Candidate should possess an entrepreneurial mindset, but understands the importance of and acts with discipline. Candidate must remain calm under pressure and tight timelines; candidate is responsive to the needs of all stakeholders, as well as takes initiative to drive results, and exercises excellent judgment. Candidate should be able to prioritize multiple expectations based on the Company’s strategy and goals, providing focus for and setting expectations with internal business partners. Candidate will tackle role with passion, commitment, enthusiasm and a can-do attitude. Candidate must work well in a team environment to influence common goals to ensure an integrated approach in pursuit of business goals, and will take on additional responsibilities/special projects, as needed. Candidate will have the ability to perform at a high professional level with a high degree of independence. Prothena is partnering with Maria Pell, Managing Director/Hechkoff Executive Search Inc. For immediate consideration please forward your resume and cover letter to: Maria Pell Managing Director Hechkoff Executive Search Inc. ******************************************************************************* APPLY FOR THIS JOB Apply URL: http://www.amgen.com/careers 4/26/2015 5 Senior Counsel Patent Biology Job ID: 23342105 Position Title: Senior Counsel Patent Biology Company Name: Amgen Industry: Biotechnology Job Function: Legal Affairs Location(s): Thousand Oaks, California, 91358, United States Posted: April 17, 2015 Entry Level: No Job Type: Full-Time Job Duration: Indefinite Min Experience: 3-5 Years Email Job Job Description The Senior Counsel will be involved in patent application drafting and prosecution, research and licensing agreements, legal opinions and strategies, trademark and copyright matters, and potentially patent litigation support. This person will be responsible for identifying patentable subject matter; drafting, filing and prosecuting patent applications; developing legal strategies relating to products and product candidates; analyzing patents and preparing infringement, validity and freedom-to-operate opinions; conducting due diligence in support of licensing activities; negotiating and drafting research agreements; and providing advice and counsel to R&D and business personnel on a variety of IP related matters. The Senior Counsel will work individually and in legal teams and cross-functional R&D and business teams. The position may be based at Amgen’s South San Francisco, CA site or at Amgen’s Thousand Oaks, CA site. Amgen is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status. To learn more about this position and to apply online, please visit www.amgen.com/careers (search under Job Number 31093BR). Job Requirements Basic Qualifications: JD degree from an accredited law school and admission to practice law required & 4 Years of experience practicing patent or intellectual property law Preferred Qualifications: - 10 plus years of experience practicing patent or intellectual property law - Experience in all aspects of U.S. and foreign intellectual property law relating to biotechnology, preferably in the pharmaceutical industry with a law firm or corporation. - An advanced degree or experience in biology - Excellent analytic, legal drafting and oral and written communication skills. - Strong management and leadership skills as well as a strong client service focus and the ability to work independently and in teams; ability to work efficiently, to prioritize workflow, to meet demanding deadlines, and to manage multi-dimensional projects in a fast-paced environment.************************************************************************** ****** https://jobs.smartbrief.com/action/listing?listingid=ED2ECBE2-B8A0-4303-84050ED74DB32E86&briefid=263A5F36-6763-46C7-B399-4428C3A9FD06&industryid=F874EF19-DAEB-45229498-02D50BEC5D3F Job Summary Date Posted: 4/22/15 Location: Santa Clara, CA 4/26/2015 6 Salary Range: Open Project Manager RA - 15000003MD Abbott Job Description Primary Job Function: As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert and resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide. Core Job Responsibilities: Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Supervisory / Management Responsibilities: Individual provides leadership without direct authority (i.e., project leader). Individual may provide direction and guidance to exempt and non-exempt personnel who exercise significant latitude and independence in their assignments. Also may mentor other department members. Position Accountability / Scope: Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues, and must assure that deadlines are met. Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements. Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Completed work is reviewed from a relatively long- term perspective for desired results. Individual is recognized as a discipline expert and resource in regulatory affairs. Influence/Leadership: · Develops, communicates, and builds consensus for operating goals that are in alignment with the division. · Provides leadership by communicating and providing guidance towards achieving department objectives. · Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units. · May lead a cross-functional or cross-divisional project team. · Provides technical leadership to business units. · Acts as a mentor to less-experienced staff. · Exercises judgment independently. Planning/Organization: · Creates immediate to long-range plans to carry out objectives established by top management. 4/26/2015 7 · Forecasts project related needs including human and material resources and capital expenditures. Decision Making/Impact: · Assignments are expressed in the form of objectives · Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. · Consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity. Minimum Education: Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) Minimum Experience / Training Required: 4-5 years experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience. ********************************************************************************** Candidates can send a resume to [email protected] or apply online: Job Summary Date Posted: 4/21/15 Location: Palm Springs, CA Years Experience: 10+ This Job appears in AdvaMed SmartBrief Director, Site Quality Management CareFusion Job Description Life-changers work here CareFusion Life-changers find innovative ways to improve our customers' ability to provide healthcare to their patients. One way is our search for bold and inspired employees across the globe. Are you ready to change lives? Join our 15,000 employees to help clinicians solve some of healthcare's most critical challenges. Meet one of our Life-changers. http://www.youtube.com/carefusion Job Title: Director, Site Quality Management https://cfn.taleo.net/careersection/2/jobdetail.ftl?job=150500B2&lang=en&sns_id=mailto CareFusion Business Description 4/26/2015 8 At CareFusion (NYSE: CFN), we are united in our vision to improve the safety and lower the cost of healthcare for generations to come. Our 14,000 worldwide employees are passionate about healthcare and helping those that deliver it - from the hospital pharmacy to the nursing floor, the operating room to the patient bedside. Our clinically proven product families include Pyxis® for medication and supply dispensing, Alaris® for infusion, AVEA® ventilators, Jaeger® for respiratory diagnostic instruments, AVAmax® and PleurX® for interventional procedures, V. Mueller® and Snowden-Pencer® surgical instruments, and ChloraPrep® skin antiseptic. To make global healthcare better, we partner with our customers to help them improve medication management, lower costs in procedural areas, reduce risk of infection, advance the care of ventilated patients and turn the endless amount of data generated in healthcare into actionable information. Learn more at www.carefusion.com Accountabilities The Director, Quality Management (Palm Springs, CA - relocation assistance is available) is responsible for providing tactical direction and management of quality and compliance activities, global supplier management, manufacturing, distribution and materials quality. This includes ensuring that products, processes and materials meet specified requirements, verifications, validations and other documentation that supports DHF, DMR and DHR. Responsible for ensuring that all aspects of quality systems including design, production, and post market surveillance by working with functional leaders in a matrix organization. The scope of responsibility spans material quality at source suppliers and continues through the full product life cycle. In addition, the Director, Quality Management will be accountable for the following: Expected to help define/establish department and policy, participate in all planning activities, lead his/her department and set an example as a leader in the business Designs, implements, and maintains quality systems which comply with Company Policies, CFR Title 21 Part 820, ISO 13485, Health Canada Medical Devices Regulation and Medical Device Directive 93/42/EEC. As the designated management quality system representative, recommends/makes quality system changes where needed to measurably improve quality/customer satisfaction Provides direction and leadership to the business unit management regarding significant product and service quality decisions. Provides quality trend information to aid in achieving those objectives. Provides direction and leadership including change management to plant quality assurance managers in order to maintain and improve quality operations within the plant. Primary liaison with FDA and international regulatory authorities for quality system compliance audits and all product actions Provides active leadership in application of lean six sigma tools and methodologies to improve plant compliance, product quality, and cycle time in quality performance. Liaise between the business unit, manufacturing, sourcing, R&D, regulatory affairs, customer advocacy and corporate quality on quality matters. Initiate and direct corrective actions related to product or process quality, including redesigns for complaint resolution, exception management, and field corrective actions. Ensures integrity of Product and Process Risk Management Responsible for Incoming material inspection process Responsible for distribution quality Provide leadership and direction to site QA management in order to continuously improve product and process quality and regulatory compliance Provides periodic detailed status reports to management demonstrating performance to department objectives, capital and expense budget and employee development initiatives. Recruit, retain, train, develop, manage and lead quality talent Manage departmental spending to the established budget(s) and lead departmental financial initiatives to effectively utilize allocated resources 4/26/2015 9 Creates systems and processes that support innovation; challenge "traditional ways", invent/apply "new ways", emphasizing and demonstrating operational excellence, while understanding the impact of change on the team and developing strategies to ensure continued team success Creates relationship internally and externally to reach consensus on complex strategic issues, leveraging cultural and individual differences among parties to maximize success and drives team through ambiguity; champions team decisions Job Family Summary QRA Management is responsible for strategic oversight and leadership direction within the QRA function. Qualifications A technical Bachelor's degree in engineering, physical science or a clinical field required, advanced degree preferred 10 years of experience in a Quality role within a FDA regulated environment Manufacturing Quality leadership experience required 5 years of direct management experience required Strong leadership, communication, and collaboration skills required Ability to convey complex ideas, impressions, and information to negotiate an outcome or influence events Inspirational leader Strategic thinking and managerial courage required Customer and patient focused individual Application of Lean Six Sigma to manufacturing processes required LSS Black Belt Certification is highly desired ASQ certifications in quality management, quality/reliability engineering, and/or quality auditing are highly desired CareFusion is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, gender identity, sexual orientation, national origin, genetic information, disability status, veteran status, or any other characteristic protected by law. ************************************************************************************ *** Sr Regulatory Analyst Thermo Fisher S. San The Genetic Systems Division of Thermo Fisher Scientific Francisco Scientific is seeking an experienced Senior Regulatory Analyst. The successful candidate will be responsible for providing Regulatory Affairs support... 05-10 04/23/15 Active Years Regulatory Analyst The Regulatory Analyst will be responsible for preparing U.S. 510(k) regulatory submissions, preparation/maintenance of Technical Files for European CE-IVD products, preparation/renewal of CMDL... Thermofisher Scientific Pleasanton, 01-05 04/23/15 Active CA Years Winning Difference United States Engineer Opportunities in San Jose include Director of ME, ME, EE, QE, Biochemist, Physiologist and so on. Details will be posted soon at... 00-01 04/20/15 Active Years ********************************************************************************* 4/26/2015 10 https://jobs.smartbrief.com/action/listing?listingid=ED2ECBE2-B8A0-4303-84050ED74DB32E86&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0199b99dc80c0&utm_source=brief Job Summary Date Posted: 4/22/15 Location: Santa Clara, CA Salary Range: Open Project Manager RA - 15000003MD Abbott Job Description Primary Job Function: As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert and resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide. Core Job Responsibilities: Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Supervisory / Management Responsibilities: Individual provides leadership without direct authority (i.e., project leader). Individual may provide direction and guidance to exempt and non-exempt personnel who exercise significant latitude and independence in their assignments. Also may mentor other department members. Position Accountability / Scope: Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues, and must assure that deadlines are met. Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements. Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Completed work is reviewed from a relatively long- term perspective for desired results. Individual is recognized as a discipline expert and resource in regulatory affairs. Influence/Leadership: · Develops, communicates, and builds consensus for operating goals that are in alignment with the division. · Provides leadership by communicating and providing guidance towards achieving department objectives. · Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units. · May lead a cross-functional or cross-divisional project team. · Provides technical leadership to business units. 4/26/2015 11 · Acts as a mentor to less-experienced staff. · Exercises judgment independently. Planning/Organization: · Creates immediate to long-range plans to carry out objectives established by top management. · Forecasts project related needs including human and material resources and capital expenditures. Decision Making/Impact: · Assignments are expressed in the form of objectives · Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. · Consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity. Minimum Education: Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) Minimum Experience / Training Required: 4-5 years experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience. **************************************************************************************** Jobs That Crossed My Desk Through April 19, 2015 ************************************************************************************* http://jobs.bio.org/jobseeker/search/results/?site_id=15768&keywords=jobs+in+California Senior Counsel Patent Biology Amgen Head of Communications Prothena Thousand Oaks, California, United States 04/17/2015 South San 04/16/2015 Francisco, California, United States ********************************************************************************** Wirth & Associates is a Pharmaceutical, Biotech and Medical Device Executive Search Firm. Below is a list of our current openings, if you have any referrals or have any staffing needs please contact our office for more information, referrals are Confidential. 4/26/2015 12 Nancy Cody Wirth & Associates [email protected] ____________________________________________________________________________________ ____ General Manager/Plant Manager TX 15 years in the pharmaceutical industry with five years of senior management experience. Strong manufacturing and technical background preferred. Gmp Liquid and cream .... OSD is a plus but not required. ____________________________________________________________________________________ ____ Director, Method Validation CA Position Summary: The Director of Method Validation is responsible for providing the day to day leadership and analytical chemistry and regulatory guidance to the Method Validation and Method Transfer sections of R&D Analytical Sciences. The responsibilities include the supervision of staff and validation projects for solid dosage and other forms from both generic and brand development areas. The responsibilities also include timely completion of validation to support ANDAs/NDAs, response to FDA deficiency letters, transfer of methods to the QC laboratories or third party and introduction of new technological initiatives. ____________________________________________________________________________________ ____ Sr. Director, Engineering Taiwan Solid Dose Experience. Manage the Engineering group in development of project scope, design, and construction of projects within agreed cost and schedule parameters. ____________________________________________________________________________________ ____ Sr. Mfg Engineer Southwest Tech Ops. Working on a project team responsible for the technical transfer of pharma products into CMO. Equipment specification/qualification, batch record writing, SOP writing, etc. Process improvement projects dealing with pharmaceutical processes. 5-10 years experience. ____________________________________________________________________________________ ____ Director, Analytical and Microbiology Southwest Provide scientific and operational leadership to the analytical and microbiology GMP laboratories ____________________________________________________________________________________ ____ Project Manager Southwest Pharma experience. Manage technical transfer of clients products into the CMO site. Includes clinical and 4/26/2015 13 commercial products. Background in mfg, eng, laboratory, etc. ____________________________________________________________________________________ ____ Project Engineer Southwest Syringe facility. Specification of utility equipment, project oversight, project schedule, construction oversight, FAT/SAT/commissioning etc. ____________________________________________________________________________________ ____ Validation Engineer Southwest Pharma experience 3-6 years, equipment qualification, requalification work, protocol/acceptance report writing. ____________________________________________________________________________________ ____ R&D (formulator). Pharmaceuticals TX Solids and Liquids Manufacturing facilities, generic pharmaceuticals. ____________________________________________________________________________________ ____ Validation Engineer TX Pharma experience 3-6 years, equipment qualification, requalification work, protocol/acceptance report writing. Troubleshooting. Oral solid and liquid products ____________________________________________________________________________________ ____ Director of Toxicology Services Northwest The Director of Toxicology Services has management oversight of the in life portion of preclinical studies. Responsible for developing and administering the programs, directing the training of employees, identifying optimal practices and facilitating change to improve efficiencies and compliance throughout the department. ____________________________________________________________________________________ ____ Quality Assurance Associate Northwest The Quality Assurance Associate will coordinate auditing activities to ensure compliance with SOPs and GLP requirements. ____________________________________________________________________________________ ____ QA Computerized Systems Auditor Northwest Performs audits of computerized systems, processes, procedures and functions to ensure compliance with 21 CFR Part 58 and Part 11 requirements. ____________________________________________________________________________________ ____ 4/26/2015 14 Sr. Director, Global Manufacturing Technical Services CA This Global position has the primary responsibility for assuring that adequate technical support is provided across all manufacturing and packaging operations. Clinical Project Manager. S.CA Dedicated to clinical research, data management, and statistical analyses and reporting servicing the biotechnology, medical device, and pharmaceutical industries. ____________________________________________________________________________________ ____ Sr. Proj. Engineer/Manager TX Mechincal/Chemical Engineer. Strong Semi Solids experience. 10m+ Projects, Budgets, Packaging, Remolding. This role is responsible for leading, coordinating and managing facility, equipment , utilities – infrastructure and process/system projects (e.g. facility expansion or redesign, new equipment or systems) including analysis, design and implementation. Oversees and manages major improvement studies. Manage projects from concept development through qualification completion. ******************************************************************************** Jobs that Crossed My Desk Through April 12, 2015 *************************************************************************************** Recent listings for California at BIO.org http://jobs.bio.org/jobseeker/job/23029839/Quality%20Assurance%20Development,%20Principal%20Spe cialist/__company__/?keywords=California&vnet=0&max=25 Advanced Endoscopist, Division of Gastroenterology and Hepatology, Stanford University Department of Medicine (Stanford, CA ) (Posted on 04/02/2015) Junior Specialist - Cell and Developmental Biology - Molecular and Cell Biology (Posted on 04/02/2015) University of California, Berkeley (Berkeley, CA ) **************************************************************************** From ScienceJobs.org I’ve listed jobs from April, 2015 Life Sciences Postdoctoral Fellow (NIM1502.15) (Posted on 04/10/2015) Palo Alto Veterans Institute for Research (PAVIR) (Palo Alto, CA ) California Institute for Water Resources Coordinator (Posted on 04/03/2015) UC, Ag & Natural Resources (Davis, CA ) Chief Software Architect/Project Manager (Posted on 04/11/2015) University of California, San Diego (San Diego, CA ) Neurosurgery Nurse Practitioner University of California, San Diego 4/26/2015 15 (Posted on 04/11/2015) (San Diego, CA ) Life Sciences Postdoctoral Fellow (NIM1504.15) (Posted on 03/11/2015) Palo Alto Veterans Institute for Research (PAVIR) (Palo Alto, CA ) Lecturer in Public Health: Summer 2015 (Posted on 04/07/2015) University of California, Merced (Merced, CA ) Associate Specialist - Department of Chemical and Biomolecular Engineering (Posted on 04/06/2015) University of California, Berkeley (Berkeley, CA ) Temecula Multispecialty Clinic CNII-Supervisor (Posted on 04/04/2015) University of California, San Diego (San Diego, CA ) Sulpizio CVC PTU Per Diem RN (Posted on 04/04/2015) University of California, San Diego (San Diego, CA ) Hillcrest OR CNII (Posted on 04/04/2015) University of California, San Diego (San Diego, CA ) House Supervisor, Admin Nurse II-Supv (Posted on 04/04/2015) University of California, San Diego (San Diego, CA ) Sr. Nursing Aid (Posted on 04/03/2015) University of California, San Diego (San Diego, CA ) Ophthalmic Technician (Posted on 04/03/2015) University of California, San Diego (San Diego, CA ) Patient Escort (Posted on 04/03/2015) University of California, San Diego (San Diego, CA ) Postdoctoral Scholar-Department of Nutritional Sciences and Toxicology (Posted on 04/03/2015) University of California, Berkeley (Berkeley, CA ) Section Chief, Gastroenterology and Hepatology, Department of Medicine (Posted on 04/02/2015) Stanford University (Palo Alto, CA ) Advanced Endoscopist, Division of Gastroenterology and Hepatology, Stanford University Department of Medicine (Stanford, CA ) (Posted on 04/02/2015) Junior Specialist - Cell and Developmental Biology - Molecular and Cell Biology (Posted on 04/02/2015) University of California, Berkeley (Berkeley, CA ) *********************************************************************************** Our startups and affiliates (QB3) are hiring. See selected openings below. We maintain current job listings at http://jobs.qb3.org/. Applicants should direct inquiries, along with current CVs, regarding this posting to the following email address: [email protected]. Research Associate: Cell Biology, Tunitas Therapeutics Tunitas Therapeutics is a privately held biopharmaceutical company that is poised to develop unique and precisely targeted protein therapeutics that will dramatically change the lives of allergy sufferers. Tunitas’ technology targets the IgE receptor on basophils and mast cells, the primary cellular mediators of allergic disease. By actively turning off signaling 4/26/2015 16 through the IgE receptor, this therapeutic approach has the potential to impact the lives of all allergy sufferers, particularly individuals with asthma and food allergy. Position Summary We are seeking a highly motivated Research Associate to join our team. This individual will play a key role in characterizing novel fusion proteins using a range of cell-based assays and employing both primary cells and cell lines. The assays will target allergic pathways, using a variety of readout technologies. In addition, he/she will assist in other aspects of recombinant protein production including transient transfections and establishment of stable cell lines. The candidate must be able to work independently and perform experiments to a very high standard, troubleshoot technical and scientific problems and effectively progress multiple projects simultaneously. This position requires strong scientific knowledge of current cell biology and molecular biology methods. The ideal candidate will be detail oriented, with excellent lab skills and maintain meticulous records. Requirements BS or MS in immunology or cell biology with 3-5 years of experience. • Experience with cell-based assay development for functional characterization of recombinant proteins • Experience with generation maintenance and characterization of novel cell lines • Experience with flow cytometry for characterization of rare cell populations • Experience with ELISA, histamine or cytokine release assays • Experience with standard molecular biology techniques • Experience with SOPs a plus • Can effectively analyze experimental data and present data at internal meetings • Maintains familiarity with current scientific literature and implements new techniques and technologies as appropriate _________________________________________________________________________ Research Associates (multiple), GALT GALT is hiring Research Associates with microbiology and molecular biology experience to help develop methods for high-throughput microbial cultivation, domestication, and screening. The Research Associate will join the Microbiology team, which supports the company’s mission of developing next generation high throughput microbiology automation equipment. At GALT, the Research Associate will work together with other scientists, including systems engineers and surface chemists, to develop protocols for high-throughput environmental microbe isolation, cultivation and screening. *Immediate responsibilities include: - Applying a range of analytical methods to characterize environmental samples, including PCR, qPCR, gel electrophoresis, spectrophotometry, and other plate assays - Building DNA libraries for NGS and Sanger sequencing - Using software tools for DNA analysis (QIIME, greengenes, BLAST) - Culturing a variety of microbes (aerobes, anaerobes, autotrophs, heterotrophs) using liquid and solid media - Supporting the development of new equipment for high throughput microbial testing, screening, isolation, domestication, and cultivation - Preparing materials including media and buffers, managing experimental schedules and processes, collecting/quantifying/analyzing/presenting experimental results - Communicating experimental results to team members and team leads The Microbiology team is integral to the design of systems that will increase accessibility to environmental organisms compared to conventional methods. Members of the Microbiology team need to have experience conducting microbial/molecular experiments, be creative, organized, energetic, collaborative, and be fully engaged in the execution of experiments. We need team members who are passionate about microbial prospecting and excited to develop new methods and protocols for the field. *QUALIFICATIONS/EXPERIENCE? We favor candidates with substantial experience designing and executing experiments in a lab setting: MS with 2+ years of working experience, or a BS with 4+ years working experience. We are interested in candidates with technical training in microbiology, molecular biology, and biochemistry. Lastly, we are looking for candidates with a history of high achievement in technical and non-technical work. ***RAs MUST have experience with NGS and microbial cultivation*** Send applications to [email protected]. 4/26/2015 17 _________________________________________________________________________ Senior Scientist – Microbiology, Bell Biosystems Company Purpose Bell Biosystems, Inc. (www.bellbiosystems.com) is a life science startup company based in Mission Bay, San Francisco that is combining synthetic biology, cell biology, molecular and medical imaging to create disruptive products for regenerative medicine, oncology and other cell-based technologies. Our first-in-class product, the Magnelle®, is derived from a non-pathogenic bacteria that produces magnetic nanoparticles from intracellular iron. This provides researchers the unprecedented ability to track transplanted cells in vivo using non-invasive MRI. We are seeking a highly motivated scientist to join our team and participate in the effort to further develop our technologies. Responsibilities Overview • Demonstrate scientific leadership and innovation in furthering the development of our Magnelles for imaging and cell tracking applications • Develop improved methods for labeling eukaryotic host cells with Magnelles, utilizing techniques such as enhanced phagocytosis, microinjection, liposome-mediated transfection, and others • Utilize methods of recombinogenic engineering and directed evolution to optimize Magnelles for optimal function within the intracellular environment • Establish and functionalize microbial strains in-house to use as the basis for additional products. Minimum Qualifications • MD or PhD in microbiology, molecular biology, synthetic biology or equivalent, with broad knowledge of intracellular pathogens, artificial endosymbionts, and broad-based genetic engineering techniques • Minimum of 5 years of post-doctoral experience with proven high-impact achievements, industry experience highly preferred • Demonstrated background culturing difficult bacteria and mammalian cells • Excellence with standard molecular biology techniques such as DNA and RNA purification, PCR, qPCR, gene cloning, western blotting, fluorescence microscopy, and flow cytometry • Skilled in construction of gene cluster plasmids and conjugative transfer • Experience in process development is desirable • Successful track record of publication and scientific presentation • Experience managing small scientific teams is preferred Personal Characteristics • High level of accuracy and attention to detail • Excellent problem solving skills and focus on process-driven results • Excellent time management and organizational skills and ability to handle multiple projects simultaneously • Ability to thrive both individually and in a team environment to achieve business goals • Comfortable working with collaborators in academia and industry • Excellent communication and interpersonal skills What We Offer • Excellent startup team in result driven environment • Opportunity to develop our innovative discovery into viable products • Comprehensive benefits package and equity commensurate with compensation Being a game-changer isn’t easy. It requires personal initiative without micromanaging. You’ll probably work longer hours than your last 9-to-5 job, but your responsibilities will be fluid and you’ll have the satisfaction of helping build something meaningful and huge from the ground up. If this fits with your career goals and you and want to play an essential role in an aggressive biotech startup, please send your CV and cover letter to: [email protected]. Please include “Senior Scientist - Microbiology” in the subject line of your e-mail. _________________________________________________________________________ Lead R&D Formulation Chemist, Acne.org 4/26/2015 18 POSITION TITLE: Lead R&D Formulation Chemist/Product Development Chemist KEY DETAILS: 6-month contract with possibility of subsequent, ongoing work. LOCATION: San Francisco, California POSITION OVERVIEW: The Lead R&D Formulation Chemist will be responsible for leading the technical development of OTC pharmaceuticalgrade skincare product formulations from the drawing board to the laboratory and be able to work under limited supervision. The Lead R&D Formulation Chemist should exhibit theoretical creativity and laboratory expertise, and possess the ability to work alongside non-scientific peers to achieve our ambitious goals. DUTIES AND RESPONSIBILITIES: • Concept to launch development of mass-market OTC topical pharmaceutical products. • Be creative: translate new product ideas into formulations that will be loved by customers. • Keep an organized work plan to ensure work is never delayed due to lack of equipment or materials. • Produce new prototype samples rapidly and precisely. • Work and communicate effectively in a cross-functional team: take instruction from the executive team and make your own contributions. • Thrive in an entrepreneurial environment with aggressive deadlines and intellectual freedom. QUALIFICATIONS: • You may be up to the task if this describes your background in Chemistry, Chemical Engineering, or a related field: • PhD and 1+ years industry experience • Masters and 3+ years industry experience • Bachelors and 5-10+ years industry experience • Other experience that qualifies you as an expert in formulation chemistry • Understand the relevance of your academic research experience to formulation chemistry. • Experience in formulation of lotions, creams, gels, and cleansers. • Strong theoretical knowledge of colloids, surfaces, emulsions, and rheology. • Masterful bench skills. You are rigorous and methodical in your lab practices to ensure your work is always reproducible. • Knowledge of acne literature a plus. • Can-do, positive attitude. COMPENSATION: • Competitive compensation commensurate with experience. TO APPLY: • Please submit a cover letter and resume/CV to [email protected] _________________________________________________________________________ Senior Scientist - Protein Expression, GigaGen GigaGen seeks a talented, highly motivated PhD-level Senior Scientist to work alongside the Director of R&D and our R&D team on research funded by a Phase I SBIR grant from the NIAID. The candidate will assist in the design of a flexible protein expression system that will enable scFv and full-length antibody protein production on a massively parallel scale. Critically, we are developing production strains and workflows for high-yield polyclonal antibody production. In later 2015, we expect that the Phase II project will involve preclinical development of a polyclonal recombinant antibody product for treatment of immune deficiencies. One or more of the following specific skills could be useful: - Deep understanding of standard genomics and molecular biology techniques, such as subcloning, multiplex PCR, and next-generation sequencing. - Experience with antibody affinity screening methods, such as yeast cell surface expression or phage display. - Knowledge of production cell genetics, with particular attention to strain engineering and protein production optimization. 4/26/2015 19 - Hands-on experience with immune repertoire sequencing, RNA-Seq, sequencing library quality control, and nextgeneration sequencing instrumentation. - Excellent writing and presentation skills. - Experience, desire, and/or interest in drug discovery and development, with a particular focus on biologics. -------------------------------------------------------------------------------Senior Scientist - Microfluidics, GigaGen GigaGen seeks a talented, highly motivated PhD-level Senior Scientist to work alongside the Director of R&D and our R&D team on research funded by a Phase I SBIR grant from the NCI. The candidate will assist in the design of an ultra high-throughput microfluidic system for generation of DNA libraries from single B cells. Critically, we are improving our current platform for 10x faster throughput. In later 2015, we expect that the Phase II project will involve preclinical development of a polyclonal recombinant antibody product for treatment of immune deficiencies. One or more of the following specific skills could be useful: - Deep knowledge of droplet microfluidics, with particular skills in prototyping and testing. - Understanding of standard genomics and molecular biology techniques, such as subcloning, multiplex PCR, and nextgeneration sequencing. - Excellent writing and presentation skills. Experience with writing patent disclosures a plus. - Experience, desire, and/or interest in drug discovery and development, with a particular focus on biologics. Email applications to [email protected]. _________________________________________________________________________ Nodexus is commercializing a novel microfluidic platform to provide fast, accurate, multi-parametric results. The Nodexus technology can count, size, and characterize particles, and the versatility of the platform makes it broadly applicable for use in several fields in the biomedical space and beyond. www.nodexus.com Senior Scientist, Cell Biologist, & Lab Manager, Nodexus We are seeking a seasoned cell biologist who will excel in the exciting, multidisciplinary environment of an early-stage Angel-funded startup company. This position will be responsible for experimental design, laboratory management, and will lead the testing of the flagship Nodexus particle screening platform. Position Overview • • • Experimental design Lead platform testing Lab management Position Requirements and Skills • M.S. plus 5+ years industry experience or Ph.D. in cell/molecular biology, bioengineering or related field with relevant post-graduate research experience and industry experience. • Extensive experience with mammalian cell culture, flow cytometry, genomic analysis, and general wet lab skills. • In addition to deep technical skills, successful candidates demonstrate strong organizational, communication and team skills, and thrive in a fast-paced start-up environment. • Proficiency in use of flow cytometers, FACS instruments, immunohistochemistry, confocal microscopy, common biological laboratory assays, cell culture management, and expert familiarity with experimental and testing design. • Experience with existing flow-based analysis and sorting technologies. The Ideal Applicant Will Be • • • Excited to work in an Angel-funded, early-stage company Able to work 5+ days/week (as needed); Immediate start date preferred Extremely motivated and be willing to work in a fast-paced environment, and with a hard-working team 4/26/2015 20 • Committed and enthusiastic about Nodexus’ mission and programs • Resourceful and flexible • Open to self-management and reporting • Able to demonstrate previous experience with delivering successful products under-budget and within established timelines • Adept at planning, prioritizing, multi-tasking, organizing and following through, while remaining highly energetic and focused • Straightforward, self-motivated, and genuine -------------------------------------------------------------------------------Senior Scientist, Microfluidics, Nodexus We are seeking a seasoned microfluidic specialist who will excel in the multidisciplinary environment of an early-stage Angel-funded startup company. This position will support the development of several aspects of the flagship Nodexus particle screening platform. Position Overview • Microfluidic device design and development Position Requirements and Skills • M.S. plus 8+ years industry experience or Ph.D. plus 5+ years industry experience in Bio/medical Engineering, BioMEMS, microfluidics engineering or related field with relevant post-graduate research experience and industry experience. • Extensive experience with microfluidic materials, design, and manufacturing. • In addition to deep technical skills, successful candidates demonstrate strong organizational, communication and team skills, and thrive in a fast-paced start-up environment. • Proficiency in use of CAD software and other Bio-MEMS design and simulation software. • Experience with a wide variety of Fluidic devices (e.g. flow cells and other microfluidic systems), preferential cell sorting, sample preparation techniques, and manipulation and filtration of cells in microfluidic formats. • Expert familiarity with existing flow-based analysis and sorting technologies. The Ideal Applicant Will Be • Excited to work in an Angel-funded, early-stage company • Able to work 5+ days/week (as needed); Immediate start date preferred • Extremely motivated and be willing to work in a fast-paced environment, and with a hard-working team • Committed and enthusiastic about Nodexus’ mission and programs • Resourceful and flexible • Open to self-management and reporting • Able to demonstrate previous experience with delivering successful products under-budget and within established timelines • Adept at planning, prioritizing, multi-tasking, organizing and following through, while remaining highly energetic and focused • Straightforward, self-motivated, and genuine Send applications to [email protected]. ************************************************************************************* https://jobs.smartbrief.com/action/listing?listingid=5B94BC6B-6B96-4925-A165-EDA7BBA3B547&briefid=263a5f366763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0&utm_source=brief Job Summary Date Posted: 3/31/15 Location: Santa Ana, CA Years Experience: 5+ in medical device development experience 4/26/2015 21 Product Development Manager, Disposable Medical Products ASAHI INTECC, Orange County CA R&D Center Job Description Job Title: Catheter Engineer ASAHI INTECC develops and supplies wire materials and products to the industries inside and outside Japan using an integrated in-house production system based on our four advanced core technologies that covers everything from selection and treatment of raw materials to manufacture of final products. In the medical field, ASAHI INTECC develops and manufacturers Asahi brand cardiovascular products such as PTCA guidewires, Guide catheter, PTCA balloon catheter, as well as OEM products, some of which have become world standards. At ASAHI INTECC our mission is to create products that perfectly match the vision of each customer. That commitment is reflected in each strand of ultra-fine wirerope that we create and each of the final products that we manufacture. [JOB Description] This position is responsible for designing, developing, and commercializing vascular catheter. [Your responsibility includes] Design, development and prototyping of vascular catheters. Design a manufacturing processes and technologies including bonding, joining, welding, braiding, coiling, plastics laminating. All research and development activities for catheter development including making a prototyping, prototype product testing. Working on product documentation including DHFs, drawings, test protocols etc.. Leading teams from conception through commercial launch of medical devices by developing design and process failure mode & effects documents. Working with Design Engineers and Quality Engineers to successfully transfer new products into production and manufacturing. [Requirement] BS or MS Degree in Mechanical Engineering, Materials Engineering, Biomedical Engineering or related Engineering Field. * 3+ years of neurovascular / cardiovascular / endovascular medical device industry experience developing catheter or catheter based medical device. Strong understanding of CAD and Computer Aided Design tools Experience working within FDA, ISO guidelines (Design Controls) and compliance with internal Quality Systems. [Benefit] 401K with company matching Group Medical Insurance Paid holidays, sick and vacation time ************************************************************************************** 4/26/2015 22 https://jobs.smartbrief.com/action/listing?listingid=1BA411DF-0A2A-4AA4-88C903C4A3CC3722&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0199b99dc80c0&utm_source=brief Job Summary Date Posted: 4/7/15 Location: Santa Clara, CA Salary Range: Open Years Experience: 8 Clinical Affairs Risk Management Scientist - 15000003AA Abbott Job Description Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 69,000 people. Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship. Follow us on LinkedIn Primary Job Function: Provides scientific expertise throughout the development and implementation of clinical evaluations and /or clinical studies. Writes/manages clinical evaluation plans or clinical trial protocols, protocol amendments, clinical study project timelines and scientific publications. Interacts with various study support groups in order to assist in clinical strategy, the development of plans, reports and project deliverables. Interacts with regulatory agencies as needed, and will use their scientific knowledge in order to provide directives to staff as well as study sites. Core Job Responsibilities: Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. · Facilitates communication between key stakeholders such as Sales and Marketing, R&D, Regulatory Affairs, PPG, Senior Management and investigational sites by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to senior staff. · Manages project timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines. · Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. · Participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction. 4/26/2015 23 · Writes clinical evaluation plans, study protocols, protocol amendments, informed consents, reports and scientific papers for publication by evaluating scientific literature, analyzing scientific data and staying abreast of current clinical practice. · Interprets results in preparation for product applications by evaluating clinical and scientific data and literature, and staying abreast of current clinical practice. · Presents scientific data by communicating accurate, succinct summaries of clinical results at industry gatherings, investigational meetings and regulatory agency meetings. Position Accountability / Scope: Understands business environment and relates extensive knowledge of internal and external technological activities to trends. Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. Participates in the development of other technical contributors by facilitating training and providing feedback and guidance. May lead a project team. Provides technical leadership to business units. Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees. Exercises judgment independently. Plans and organizes project assignments of substantial variety and complexity. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives. Minimum Education: Bachelor's degree required, advanced degree preferred (MD or Ph.D.). Degree in the sciences, medicine, or similar discipline highly preferred. Minimum of 8+years of related work experience with a complete understanding of specified functional area, or an equivalent combination of education and work experience. Minimum Experience / Training Required: Comprehensive knowledge of a particular technological field. Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships. Is recognized as an expert in work group and across functions. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business. Experience with ISU's (Instructions for Use). Seeking experience in Clinical Development, Clinical Research, Study protocols and/or in risk management. ************************************************************************************* Our startups and affiliates are hiring. See selected openings below. We maintain current job listings at http://jobs.qb3.org/. Please send your resume to [email protected] with "Laboratory/Process Technician" in the subject line. This position is to be filled ASAP. No submissions will be accepted after 5/1/2015. If you would like to post an opening on our website, please contact us with your name, email address, and company name. We will forward this to VentureLoop, the third party who manages our job listings. They will contact you and set you up with access to a free account so you can manage your own posting details. Customer Support Associate, Blueprint Genetics Blueprint Genetics is a sequencing technology and genetic information company. This academic spin-off company was founded in 2012. We have further developed a Stanford University innovation called oligonucleotide-selective sequencing, OS-Seq, which represents the most effective targeted sequencing strategy in the market (Myllykangas et al 2011, Nature Biotechnology). Blueprint Genetics has harnessed this technology together with our in house built bioinformatics to produce comprehensive and high quality genetic diagnostics tools for clinical diagnostics market. The headquarters of the company are in Helsinki, Finland. We are now in the process of expanding our global sales to the United States and we have opened an office in San Francisco. 4/26/2015 24 We are an enthusiastic and ambitious team of biologists, physicians, bioinformaticians, geneticists, sales and lab personnel aiming to change the standards of genetic diagnostics. We are now building the US operations and the team to expand our services in North America. We are looking for an intelligent, organized, creative, social, proactive, well-written person to fill our Customer Support Associate position. In this job, one of the main tasks will be customer support therefore we are looking for a personality who enjoys customer service and has the essential social and communication skills to succeed in this position. You will also have a supportive role for our US sales team and the General Manager of US organization. You will be responsible for handling the diagnostic sample flow coming through our US office. We receive samples from Monday to Saturday. In this position you will take part in building and organizing the US operation. Your Primary activities will include - Provide customer support through phone and email. - Handle the diagnostic sample flow – will require Saturday duty when expecting sample deliveries. - Provide support for the sales team - helping schedule and plan meetings and travel for our sales team; assist email and mail campaigns. - Assist invoicing and reimbursement procedures. - Planning, organizing, and executing events, seminars, and other activities. - Assisting our team in planning internal and external company events with customers, collaborators and investors. Required Skills: - Customer service personality. - Excellent listening, oral, and written skills – it is all about communication. - Good organizational skills. - Energy and enthusiasm helps to survive in a start-up environment. - Ability to plan and organize simple to complex events. - Comfortable working in a fast-paced, small team environment. - Excellent time management and prioritization. Education/experience: - 1-2 years of Office management experience in a fast-paced environment. - Any customer support experience is considered beneficial. - Background in science - preferably life science is helpful in a genetic diagnostics company. - A bachelor's degree is preferred. _________________________________________________________________________ Formulation Scientist, ZoneOne Pharma ZoneOne Pharma is developing nano-chelation technologies for orphan drug disorders. Our primary focus is ironoverload. Additional programs involve partnerships with pharmaceutical companies or government agencies. ZoneOne Pharma is looking for a highly motivated Formulation Scientist with experience in liposome formulation and characterization. Experience with scale-up, GMP manufacturing and GLP analysis (HPLC) is a plus. The ideal candidate is high-energy, self-motivated and innovative. M.S or Ph.D. in chemistry, physical chemistry, chemical engineering, pharmaceutical sciences or related fields preferred. Division of time and duties: Laboratory Work 80%: Laboratory Work is defined as general wet lab procedures including: ● Preparation of liposomes: development of novel liposome formulations, preparation of liposomes for characterization, preparation of liposomes for evaluation in storage, cell culture studies, and animal studies. ● Characterization of liposomes: analysis of drug and lipid content, determination of size and zeta potential, analysis of targeting ligand density. ● Analytical method development: design, test and validate new HPLC methods. ● Evaluation of liposomes: stability in storage and in plasma, performance in cell culture studies including cell binding/accumulation and cytotoxicity, performance in animal models including plasma/tissue analysis. ● Formulation scale-up: assess and optimize process conditions for scale-up manufacturing of Z1P’s lead liposomal drug product (Z-204) to support key preclinical toxicology and efficacy studies. Aid in design and preparation of CMC documentation. ● Stability Studies: conduct drug product stability studies on Z-204 and other prototype formulations. 4/26/2015 25 ● Cell Culture: maintain cell lines in culture, perform in vitro studies. Lab Support 10%: ● Batch Records: Write batch records for API, excipients and processes used in liposomal formulation development. ● Notebooks: Keep up to date and signed record of all, rationale, experimental procedures and results. ● Process Data: Work up data from laboratory procedures into a format that can be shared in a report or presentation form. ● Analyze and interpret data: Present your conclusions on the meaning of results obtained in your studies. Scientific Research Support 10% ● Literature search and reading. Please submit CV to [email protected]. _________________________________________________________________________ Laboratory/Process Technician at Nano Precision Medical Nano Precision Medical is a start-up medical device company located in Emeryville, CA. We are developing a small, implantable device to improve treatment for people suffering from chronic diseases by providing sustained medication levels over several months without the need for injections. Job description: We are seeking a Laboratory/Process Technician who will help manufacture the next generation of drug delivery device in our development manufacturing facility. As a Laboratory/Process Technician, your primary duties will include: • Following procedures to produce and test parts as part of a development manufacturing line. • Keeping detailed electronic and/or written records of process and test results. • At times, evaluating and giving feedback to engineering staff on new process development. • Working with engineering staff on developing new documentation on process developments. • Maintaining and troubleshooting test apparatus and manufacturing fixtures. • Candidates must be comfortable working in a laboratory environment and be familiar with good laboratory practices (GLP) as well as be able to work independently while multi-tasking in a fast paced environment. Minimum Qualifications: • 1-3 years of experience in a biomedical or medical device company. • Experience with Microsoft Excel, Word, and general computing. • Demonstrated ability to work well with others in a team environment. • Ability to follow written procedures or verbal instruction. • Desire to contribute proactively to a constant improvement effort. Desired Qualifications: • Bachelor’s degree in STEM-related field. • Experience with experimental design. Our mailing address is: QB3 UCSF MC2522 1700 4th St., Byers Hall, Suite 214 San Francisco, CA 94158 USA ************************************************************************************ If interested please apply online and send me a copy of your resume to [email protected] I'm in search for a great ME with 5-8 years work experience. For more detail you can check careers tab on www.spectranetics.com ***************************************************************************** 4/26/2015 26 https://jobs.smartbrief.com/action/listing?listingid=5BBF0141-AA19-47EC-910C33EE48F1BF1A&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0199b99dc80c0&utm_source=brief Job Summary Date Posted: 3/25/15 Location: Santa Clara, CA Salary Range: Competitive Years Experience: 10 years This Job appears in AdvaMed SmartBrief Compliance Director Abbott Laboratories Job Description Description – External Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people. Primary Job Function Provides direct oversight for Abbott’s ethics and compliance program at Abbott Vascular. Responsible for directing the development and implementation of Office of Ethics and Compliance (OEC) policies and procedures, education and training, compliance monitoring and risk assessments. Regularly communicates with division management on the state of the compliance program and partners to develop action plans to manage compliance risks. Core Job Responsibilities Provide leadership, guidance, and support to all levels of divisional business functions on highly complex ethics and compliance issues, including policy interpretation, compliance risk assessment, trend analysis and best practice recommendations. Resolves highly complex ethics and compliance matters that have significant and possibly material impact to Abbott. Directs and conducts periodic reviews and updates to OEC policies and divisional procedures, ensuring clarity, applicability and alignment with higher level policies and external requirements, with minimal supervision from the Ethics and Compliance Officer. Develops, implements, delivers, and updates OEC’s comprehensive training program on complex divisional policies and procedures. Provides oversight to corporate and/or divisional monitoring process to ensure compliance with OEC policies and procedures. Reviews industry trends and internal monitoring results to recommend corrective actions. Partners with the Ethics and Compliance Officer and business on compliance audits, oversees the fulfillment of auditor’s requests, acts as liaison between the business and auditors during on-site activities, evaluates and responds to 4/26/2015 27 all preliminary findings and recommendations, and guides the business in preparing corrective actions to address all findings and recommendations. Oversees the Compliance Review Committee at the divisional level and provides input on handling violations. Reviews internal trends and implements corrective actions. Provides leadership and guidance on proposed commercial programs, identifies complex legal and regulatory issues, analyzes alternatives and works with the Legal Department, as appropriate, to propose solutions to the business. - Possesses in-depth knowledge of Abbott’s businesses and knowledge of the broader business impact. - Leads highly complex cross-functional teams. This position has direct report(s), so there is an emphasis on people management, including mentoring, coaching, and developing direct reports and others on the team. - Also plays a key role in selecting, recruiting, and developing team members. - Assists the Ethics and Compliance Officer in succession planning for the department. Position Accountability/Scope - Accountable to the Ethics and Compliance Officer. - Assigned matters / division(s) have significant and possibly material impact to Abbotts’s compliance program. - Operates with autonomy and limited supervision. - Provides guidance and direction to Coordinators, Compliance Analysts, and Compliance Managers, as needed. ************************************************************************************** Jobs that Crossed My Desk Through March 29, 2015 *************************************************************************** If you have appropriate experience, bandwidth and interest, please let David Madden know. David Madden [email protected] I have a client that needs to engage a technical writer with expertise in protocol development, clinical development plan and regulatory dossiers (primarily IND). The company has three preclinical small molecules in the GI space. Work would be sporadic. ****************************************************************************** OUTSTANDING OPPORTUNITIES AT TRICIDA (Medical Director, Mgr. Regulatory, & Staff Scientist): https://lnkd.in/ePPmy_t Tricida is headed by an extremely brilliant leadership team who have previously worked together 10+ years, with recent Series B $30 M closing, to total $40 M raised. This team has raised over $250 M in VC, i.e. Relypsa and Ilypsa. Tricida is transitioning from research to product development, focusing on discovery and clinical development of novel therapeutics to address CKD, metabolic and cardiovascular diseaseless Tricida, Inc. Tricida, Inc. is an innovative startup company focused on the discovery and clinical development of novel therapeutics to address renal, metabolic and cardiovascular disease. Tricida is led by a management team with an accomplished and proven track record in discovering and developing new therapeutics, with 4/26/2015 28 extensive experience in building successful companies around strong science and unmet medical needs. The Company is backed by world-class venture capital firms. We are expanding our existing group of exceptionally talented and well-motivated scientists and physicians to bring new drug candidates into clinical development. Associate Medical Director, Clinical Development Summary Reporting to the Chief Scientific Officer, the successful candidate will lead Tricida’s worldwide TRC101 clinical development program. You will participate in defining medical strategies that create a robust and efficient TRC101 clinical development plan, while ensuring a comprehensive clinical assessment of TRC101 safety and efficacy. Your strong technical knowledge of drug substance and drug product processes, along with analytical and CMC-related topics will prove invaluable, in addition to your experience in assessing regulatory requirements for clinical trials conducted within a given therapeutic area. You will align the target product profile of TRC101 with medical and market needs, while enhancing organizational knowledge of the US medical/clinical environment served by TRC101, in anticipation of late-stage development. In addition, you will participate in Company scientific meetings as required, including interactions with the FDA, thought leaders in the nephrology and cardiology community and investors. Responsibilities Include: • Contribute to the development and design of safety and proof of concept human clinical studies that meet scientific, regulatory, clinical and operational requirements. • Organize and lead clinical studies, interpret clinical data, and make appropriate recommendations for further drug development based on these data. • Lead the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction. Provide project leadership and scientific expertise throughout the development and implementation of local and global clinical studies. • Write study protocols, protocol amendments, informed consents, clinical study project timelines and scientific papers for publication. • Evaluate and summarize appropriate scientific literature and publications, analyzing scientific data and staying current with standard of care clinical practice. • Interact with various study support groups (CMC, pharmacology, toxicology) in order to assist in clinical strategy, the development of study plans, and project deliverables. • Manage clinical study timeline and budget by using the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines. • Interact with regulatory agencies, key opinion leaders and investors as needed. Provide clinical input for new product development, post market surveillance, recertification and business development. • Facilitate regulatory submissions and communications by working with Regulatory Affairs during the submission process. This will entail the provision of accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies, Institutional 4/26/2015 29 Review Boards, and Medical Ethics Committees; may also include clinical risk management activities such as input into Hazard Analyses, product FMEA and DFUs and authorship of Clinical Evaluation documents (CES, CRBA, CDSR) for support of safety performance for product approval. • Present scientific data by communicating accurate, succinct summaries of clinical study work at industry gatherings, investigational meetings and regulatory agency meetings. • Serve as a medical advisor to drug discovery teams and participate in selection of discovery compounds based on medical need and compound characteristics, including in vitro and in vivo pharmacology. Contribute to strategic review of research in renal, metabolic and cardiovascular disease mechanism of action studies. • May perform additional responsibilities, as deemed by the executive team. Experience and Skills: MD, DO or PharmD; preference given to those individuals Board Certified in Nephrology or Internal Medicine. Minimum of 2+ years of experience as a clinical research scientist; strategic experience in clinical trial study design and implementation within the biotechnology or pharmaceutical industry; experience in renal, metabolic and/or cardiovascular clinical trial design preferred. Experience conducting biopharma research and in evaluating, interpreting and presenting complex scientific data. • Experience in fields such as drug metabolism, ADME, pharmacokinetics, clinical pharmacology, toxicology or medicinal chemistry is a plus. • Ability to establish effective relationships with investigators and study staff, with ability to influence diverse teams and key stakeholders. • Strategic, analytical, critical thinker with outstanding communication skills. • Ability to travel app. 30-40%, domestic and international. Competitive Compensation and Benefits include: Medical, Dental, and Vision Coverages, Life, AD&D, Disability, 401(k), Flexible Spending Plan, and Pre-IPO stock options. 15 vacation days per year and 11 paid holidays per year, which includes 1 floating holiday. Tricida is located in South San Francisco, CA. SEND RESUMES TO: [email protected] and indicate Job Code JB001 ____________________________________________________________________________________ _______EOE Job Code: SM002 LOCAL CANDIDATES ONLY Tricida, Inc. is an innovative startup company focused on the discovery and clinical development of novel therapeutics to address renal, metabolic and cardiovascular disease. Tricida is led by a management team with an accomplished and proven track record in discovering and developing new therapeutics, with 4/26/2015 30 extensive experience in building successful companies around strong science and unmet medical needs. The Company is backed by world-class venture capital firms. We are expanding our existing group of exceptionally talented and well-motivated scientists and physicians to bring new drug candidates into clinical development. We seek a regulatory professional who will work through regulatory topics concerning manufacturing, nonclinical and clinical aspects of investigational product development, while employing sound working knowledge of GXP practices. In this important role, you will partner with the Sr. Director of Regulatory in developing and implementing regulatory strategies to secure and maintain market access for assigned product(s) in line with business objectives, and in coordination with key internal stakeholders. Responsibilities Include: Prepare regulatory submissions for investigational products in line with ICH and regional requirements, as well as company policies and procedures, ensuring that regulatory documentation meets relevant regulatory requirements o Contribute to the preparation of global regulatory strategies and plans for targeted countries, including review of existing regulatory guidelines, competitor products, and relevant literature o Maintain current knowledge of US and international regulations and standards affecting Tricida; develop detailed understanding of regulations, regulatory guidelines and technical requirements in target countries and a broad understanding of the global regulatory environment o Contribute to the development of proactive strategies for maintaining compliance with changing regulatory requirements in US and international markets o Collaborate with other Regulatory team members to coordinate requirements for US and international regulatory submissions o Communicate with internal and external technical experts responsible for the preparation of documentation for inclusion in regulatory submissions, and apply regulatory expertise to facilitate the preparation of high quality regulatory documentation o Prepare and/or contribute to the preparation of original IND(s) and CTA(s) and other submissions which may include safety reports, IND amendments and CTA supplements o Ensure management is kept apprised of status/progress and updates of regulatory filings Actively participate in product development teams, reviewing project plans to ensure that all US and international regulatory requirements are identified as early as possible in the product development process Contribute to the creation and periodic update of Regulatory policies and procedures (SOPs); undertake assigned regulatory projects, including review of guidelines and contribute to the improvement of departmental and divisional processes; assist in the review and approval of policies and procedures for other Tricida departments (e.g., Quality Assurance, Clinical Operations, etc.) Ensure that comprehensive and accurate records of communications, country requirements and regulatory status, are maintained Assist in preparing presentations, updating project plans, preparing for due diligence activities, etc. May perform additional responsibilities, as deemed by management Experience and Skills: Bachelor of Science degree (Life Sciences, Chemistry or Chemical Engineering preferred) Minimum of 7+ years of progressive Regulatory experience with demonstrated experience in coordinating regulatory submission preparation for drug/biologic products in clinical development Understanding of regulatory requirements, including ICH and regional requirements for assigned territories Proven ability to manage or contribute directly to the resolution of complex regulatory, or drug development, issues 4/26/2015 31 Experience working in cross-functional, global, virtual environments. Excellent interpersonal and organizational skills, with an ability to build relationships at all levels of the organization, including external vendors Demonstrated ability in strategic thinking, critical thinking and analytical skills Adept at working on concurrent projects with tight timelines, with capacity to react quickly and decisively in unexpected situations RAC certification, and prior experience with electronic submissions are pluses Strong business acumen and ability to see the business drivers outside of Regulatory Affairs Ability to travel up to 10%, domestic and international Competitive Compensation and Benefits include: Medical, Dental, and Vision Coverages, Life, AD&D, Disability, 401(k), Flexible Spending Plan, and Pre-IPO stock options. 15 vacation days per year and 11 paid holidays per year, which includes 1 floating holiday. Tricida is located in South San Francisco, CA. EOE ____________________________________________________________________________________ To apply for this position, please send your resume to [email protected] and indicate Job Code GC001. Staff Scientist, Analytical Development and Quality Control Job Code: GC001 LOCAL CANDIDATES ONLY Tricida, Inc. is an innovative startup company focused on the discovery and clinical development of novel therapeutics to address renal, metabolic and cardiovascular disease. Tricida is led by a management team with an accomplished and proven track record in discovering and developing new therapeutics, with extensive experience in building successful companies around strong science and unmet medical needs. The Company is backed by world-class venture capital firms. We are expanding our existing group of exceptionally talented and well-motivated scientists and physicians to bring new drug candidates into clinical development. Summary: You will play an integral role in developing and implementing analytical strategies required for characterization, testing and release of product to support pre-clinical studies and subsequent clinical trials. Responsibilities Include: Develop analytical methods for release testing of starting materials, intermediate, drug substance and drug product Evaluate and improve existing analytical tests and assays Conduct routine testing of samples to support process development and product development efforts Validate analytical methods for QC release testing of intermediate, drug substance and drug product Write analytical test methods, protocols and reports as part of analytical transfers to CROs/CMOs for GMP testing Troubleshoot method, hardware and software issues, as well as maintain laboratory equipment (log books, inventory of consumables) Review data and related documents generated from analytical testing of drug substance from external GMP testing sites Experience and Skills: 4/26/2015 32 B.S. in analytical chemistry or related disciplines, with minimum of 8 years relevant experience. Alternatively, an M.S. with minimum of 5 years or a Ph.D. with minimum of 2 years relevant experience may be substituted Extensive knowledge and hands-on experience on chromatographic techniques (IC, GC and HPLC) Knowledge of techniques required for physicochemical characterization of drug substance (Particle size, XRPD, TGA, DVS, and DSC etc.) Hands-on experience with analytical method validation in a regulated environment is a plus Must have excellent working cGMP knowledge and documentation practice Familiar with reference standard characterization for drug substance and related substances Attention to detail as applied to data review; excellent analytical skills applied to investigations Must be self-motivated, detail-oriented, and flexible in handling project assignments Must demonstrate strong communications, organizational and interpersonal skills within a teamoriented environment Competitive Compensation and Benefits include: Medical, Dental, and Vision Coverages, Life, AD&D, Disability, 401(k), Flexible Spending Plan, and Pre-IPO stock options. 15 vacation days per year and 11 paid holidays per year, which includes 1 floating holiday. Tricida is located in South San Francisco, CA. ********************************************************************************* Qualified candidates please reply to: Cindy Johnson [email protected] tel: 925-577-8135 REGULATORY, QUALITY & CLINICAL AFFAIRS *URGENT* (Sr.) Director, Quality Engineering (open to Sr. Director level) BS in a related engineering discipline 10-15 years of related QE experience and/or training preferably in medical device industry Advanced engineering degree (MS, PhD) with relevant years of industry experience Knowledge of statistics and minitab is required Certification and/or license in a specific discipline is a plus Proven & effective team leadership and management skills Medical device industry experience is required Certified Quality Engineer/Manager is preferred Training in 6-sigma techniques is a plus. Sr. Quality Engineer BS in Engineering, advanced degree preferred Knowledge of statistics and minitab is required 5+ years QE experience in the medical device industry Certified Quality Engineer is preferred Possess Certification as a Lead Auditor in ISO 13485:2008 MANUFACTURING, OPERATIONS & R&D ENGINEERING Manufacturing Engineering Manager BS degree in relevant engineering discipline, advanced degree preferred Experience with Nitinol processing is preferred Strong people management experience is required 8 – 10+ years manufacturing engineering experience within medical device industry Possess excellent oral & written communication skills Process Engineering Manager BS degree in a relevant engineering discipline, advanced degree(s) preferred 8 – 10+ years experience in process engineering within medical device industry Proven and effective people management skills Solid background in AutoCad and SolidWorks Possess excellent communication skills - written and oral Mechanical Laser Process Engineer BS degree in relevant discipline, advanced degree is preferred 4/26/2015 33 3 - 5+ years of relevant engineering experience in medical device industry Laser experience and a mechatronics background SolidWorks background Manager, Equipment Engineering BS Engineering degree required, advanced degree is a plus 8 – 10+ years of relevant engineering experience Six sigma, process excellence experience preferred Strong people management skills required Broad-based knowledge relating to software and control systems required Strong analytical problem-solving and interpersonal skills, leadership skills, technology management and customer-focused decision making Sr. Process Development Engineer (thermo-mechanical processing) Bachelor's degree in related engineering discipline. 5+ years experience in process development engineering. Experienced in incorporating radiopaque markers Ability to communicate clearly and efficiently in a highly technical environment. Capacity to work independently, with minimal supervision. Experience working in a regulated environment is a strong plus Experience with gage R&R, DOE set-up and analysis Experience with SolidWorks Sr. Process Development Engineer Bachelor's degree in Mechanical, Industrial, Biomedical, Materials or Chemical Engineering, or related discipline. 5+ years experience in process development engineering. Ability to communicate clearly and efficiently in a highly technical environment. Capacity to work independently, with minimal supervision. Experience working in a regulated environment is a strong plus DOE set-up and analysis is a plus Model Shop Manager BS degree in relevant discipline preferred. 8+ years of related machine shop management experience with considerable knowledge of the tools, equipment, materials, methods, and standard practices of the trade. Considerable knowledge of the cleaning, repair, and PMs on CNC equipment, manual operated equipment, and tools. Minimum 3-5 years experience with operation of 3 and 4 axis CNC Machines, tool setup, and inspection in prototype and production environments. Minimum of 3-5 years experience managing schedules, workflow, safety, personnel, and equipment. Minimum of 3-5 years experience with software applications such as Solid Works, CAM Works, G Code. Experience with model shop scheduling, estimating, setting up, and reporting of jobs. Experience with HAAS, and Fadal CNC equipment, and with Sodick EDM equipment. Experience in the medical device industry and with machining of Nitinol material is preferred Experience with GDT, 5S and LEAN manufacturing principles is preferred SALES, MARKETING, BUSINESS DEVELOPMENT & CUSTOMER/PRODUCT SUPPORT Marketing Manager Bachelor's degree, MBA a plus Minimum 5 years of progressive marketing experience within the surgical device industry, previous experience in otolaryngology (ENT) or office-based medical procedures a plus Ability to work well in a start-up environment, exhibiting flexibility, self-sufficiency, and an ability to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other company team members Excellent communications, personnel management, and operational skills Strategic thinker, able to position company and products for success. Strong leadership, team building, negotiation, presentation and communication skills. Ability to develop strong relationships with key opinion leaders. Approximately 30% travel 4/26/2015 34 ***************************************************************************** https://jobs.smartbrief.com/action/listing?listingid=A9A1ECF6-5FCB-4B92-9754F85AF9634EED&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0199b99dc80c0&utm_source=brief Job Summary Date Posted: 3/17/15 Location: Santa Clara, CA Sr Statistician I (US/TB/00/0028/SL) Abbott Job Description Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 73,000 people. Visit Abbott at http://abbott.com/index.htm and connect with us on Twitter at @AbbottNews. Follow us on LinkedIn Primary Job Function PROTOCOLS INPUT, RANDOMIZATION SCHEDULE, AND DATABASE ACTIVITES Works with project team to decide on appropriate study design and statistical methodology Responsible for comprehensive protocol review Responsible for randomization schedule, sample size and power calculations Responsible for assuring that data for statistical analyses are accurate STATISTICAL ANALYSES Responsible for implementation of protocol methodology and statistical analysis plans Responsible for the accuracy and timeliness of statistical input into reports or decisions Responsible for validity of alternative analysis strategies when changes to planned analyses are needed Responsible for computer programs that are accurate, efficient and well documented Demonstrates extensive understanding of statistical concepts and methodologies SCIENTIFIC REPORTS AND PUBLICATIONS Responsible for Statistical Methods section Responsible for accuracy of statistical tables and data listings, and accuracy of report text Identifies and corrects flaws in interpretation of results, inconsistency in presentation or inference Provides significant and timely input to the development of a report strategy CONSULTATION Works collaboratively with peers to develop efficient designs, quality protocols and reports per agreed timelines Provides accurate and timely answers to routine questions from clients, and scientific insight when answering nonstandard questions Effectively presents statistical concepts and arguments to management TRAINING, SUPERVISION, MENTORING Effectively mentors less experienced statisticians Can provide formal training to non-statisticians Seen as a project leader on key initiatives Project Coordination and Regulatory Activities Coordinates and leads the work of the section in multiple project areas ensuring that statistical support meets regulatory needs Effectively interacts with project leaders and regulatory affairs Responsible for the accuracy and appropriateness of statistical input (e.g., protocol design, statistical methodology, interpretation of results and inference) provided for regulatory submissions, discovery and development decisions Core Job Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Ensures accuracy of report text and consistency between summary tables in the body of reports and the corresponding statistical tables and listings. 4/26/2015 35 Responsible for statistical methods Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, and adherence to Abbott report guidelines. Provides meaningful input to the development of a report strategy. Works collaboratively with peers to develop quality protocols, CRF, schema, and reports per agreed timelines. Provides accurate and timely answers to routine questions from clients, scientific insight when answering nonstandard questions, and independently pursues analyses suggested by the data. Communicates an understanding of basic clinical principles for his/her project and acts in accordance with those principles. Can clearly communicate basic statistical concepts to other scientists and nonscientists. Informs supervisor or manager on important issues in a timely manner. Effectively mentors non-statistical peers with regard to basic statistical methodology and departmental operations. Position Accountability / Scope Position interacts with customers from throughout the division. Often required to reconcile multiple and potentially conflicting priorities. Effective communication with various levels of personnel is required regularly. Problem Solving: Works collaboratively with multiple stakeholders to develop scientifically appropriate development strategies per agreed upon timelines. Communicates an understanding of product development principles for assigned projects and acts in accordance with those principles. Effectively and persuasively presents statistical concepts and arguments to management, regulatory agencies, scientists and nonscientists. Minimum Education Advanced degree (MS, MA, PhD. or equivalent) in Statistics or Mathematics Minimum Experience / Training Required MS/MA with 3+ years related work experience or PhD with 1+ years of related work experience. ************************************************************************************ **************************************** http://jobs.bio.org/jobseeker/job/22686922/Senior%20Specialist%20Quality%20Assurance%20Developm ent%20Project/__company__/?vnet=0&keywords=california&max=25 Senior Specialist Quality Assurance Development Project Job ID: 22686922 Position Title: Senior Specialist Quality Assurance Development Project Posted: Company Name: BAYER Entry Level: Location(s): Berkeley, California, 94704, United States March 16, 2015 Job Function: Other No Job Description Description Senior Specialist Quality Assurance Development Project Bayer is a global enterprise with core competencies in the fields of health care, agriculture and high-tech polymer materials. As an innovation company, it sets trends in research-intensive areas. Bayer's products and services are designed to benefit people and improve their quality of life. Bayer HealthCare (BHC), an Equal Opportunity Employer, makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches promoting science for a better life throughout everything that we do. Our Divisions include Specialty Pharmaceuticals, Medical Care, Consumer Care and Animal Health. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change. QA Devp Change Mgmt Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the 4/26/2015 36 requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. To all recruitment agencies: Bayer does not accept unsolicited third party resumes. •Provides Quality Assurance oversight for Biotech Development. Assures quality requirements, appropriate for clinical phase of the development project, consistent with current regulatory requirements are in place and being met. Executes QA activities for development projects including those that allow manufacture of and release of Biotech investigational products, both in-house and at Contract Manufacturing facilities. •Administers and maintains the development change control system by adhering to procedures and systems to handle change management/change control requests (CCRs). Evaluates and/or approves change control documentation using scientific principles, thorough risk and impact analysis, and compliance minded thought processes in order to meet cGMP requirements within established timelines. Ensures that all CCRs are reviewed at the appropriate levels by appropriate groups. •Reviews/approves MBRs/SOPs and specifications under the direction of QAD Sr management; reviews and approves regulatory submissions by providing input to the Quality and compliance content of Technical Registration Documents (TRDs) and responses to agencies. •Represents Quality Assurance Development on Technical Development Team (TDT), as assigned. •Utilizes technical and scientific knowledge to support technical transfer of manufacturing processes including analytical methods, for successful licensure and product launch. •Leads multi-functional discussions during the course of significant investigations bearing potential product quality impact. •Performs investigations and writes QA investigation reports to support Product Technical Complaints related to development products for Phase I, II and III clinical trials. •Assists in the preparation, negotiation, approval and ongoing management of QAAs with contract manufacturers and suppliers of and service providers for Biotech investigational products and other development projects •Bachelor's degree in a scientific or technical field. •Minimum 6 years of overall experience in the biopharmaceutical, biologics, medical device or related industry, along with knowledge and understanding of cGMP concepts, and applicable US and foreign regulations. A minimum of four years of direct experience in Manufacturing and/or Quality in a GMP-regulated industry or an equivalent combination of education and experience. •Knowledgeable in Biotech quality management methodology. Ability to provide input regarding product quality assessments, quality system design, and related tasks and tools, as well as their improvement. •Must be able to understand, review, and approve change control documentation. •Prior experience in product development change control management per current ICH Q8, Q9, and Q10 is desirable. •Demonstrated success in scientific/technical proficiency, collaboration and leadership skills, and independent thinking. •Experience with electronic change management database (e.g. ValGenesis) a plus. •Proven ability to work in a complex business environment under competing priorities. Ability to be flexible without compromising compliance. •Strong written and oral communication skills • Project management skills •Ability to work with and influence a diverse group of peers of widely varying technical abilities, and ability to communicate cGMP requirements to peers and colleagues from other departments. •Experience in discrepancy management and/or method validation a plus. Preferred Qualifications: •Advanced degree is preferred. Bayer is an Equal Opportunity Employer Minorities/Females/Protected Veterans/Disabled Your application We offer a wide variety of competitive compensation and benefit programs. In addition to a competitive base salary, you will be eligible for an array of innovative rewards and recognition programs, variable pay and incentive opportunities as well as benefits coverage beginning on your first day of employment. We are committed to helping our employees maintain a healthy balance between their responsibilities at work and home. You will be eligible for paid time off programs, paid company holidays, flexible work options and numerous site conveniences. We are also committed to supporting your professional development through career ladders, training programs, tuition assistance and professional association events.# www.myBayerjob.com Phone +1 877 229-3727 ********************************************************************************** http://massdevice.simply-partner.com/job-post/50775.32853 Senior Clinical Research Associate Claret Medical, Inc. 4/26/2015 37 Santa Rosa, CA Posted 3 weeks, 1 day ago This position will help facilitate the planning, management and execution of clinical evaluation of a novel neuroprotection technology in a US IDE Clinical Trial in the setting of Transcatheter Valve Replacement (TAVR) technologies. Responsible for key project areas of site management, device training management, multiple core lab management, and executing strategies for clinical trials for product releases, regulatory filings, and product modifications/claim extensions. Supports the Head of Clinical Affairs and the company in the design, initiation, conduct, monitoring, and close-out of the IDE. Experience in managing DSMB and CECs is strongly preferred. Works closely with study coordinators and investigators to ensure compliance with protocol and overall clinical objectives. In collaboration with clinical team and CRO, maintains consistent CRF data quality and discrepancy interpretation across sites. Maintains high level of professionalism within company and at the study sites. Ensures adherence to Good Clinical Practice (GCP) and department standard operating procedures for conducting clinical studies. Prioritizes and focuses resources to deliver all projects in a timely manner in keeping with the groups commitments. This position reports to the Senior Director of Clinical Affairs. Technical or nursing educational background or direct experience in implanted valve studies would be beneficial. ************************************************************** Please submit your resume and a brief cover letter to [email protected] or upload via our website. Operations Manager AdvancedCath San Jose, CA Posted 3 weeks ago AdvancedCath, formerly AdvancedCath Technologies, MP&E, LSA Laser and TechDevice, are leading players in the design, development and manufacturing of advanced catheter systems. AdvancedCath works with medical device OEMs to design and manufacture catheter and guidewire systems used in complex interventional and endosurgical procedures. We currently have an opening for a Operations Manager in our San Jose, CA facility. The Operations Manager establishes priorities and ensures that scheduled deadlines and quality standards are met. Proactively identifies issues, develops procedures and provides the appropriate training and equipment to employees. Ensures the company is providing cost effective, high quality products to customers. Experienced in Lean Manufacturing concepts and tools Key Responsibilities: Oversee and manage all aspects of the manufacturing operation in assigned area. Responsible for achieving delivery, quality and cost containment goals. Develop and execute daily, weekly and monthly production schedules to meet business needs as well as departmental objectives. Ensure processes and equipment operate within specification, capacity and capability tolerances Recommend and execute personnel actions including hiring, promotions, performance reviews and disciplinary actions. Determine and implement operational capabilities required to support company growth and strategies. Reduce manufacturing operating costs through innovation and productivity Generate and modify manufacturing process documentation. Manage, maintain and enhance all procedures, work instructions and other documentation in meeting ISO 13485 standards. Assist with development of manufacturing processes, tooling, and fixtures that result in sufficient capacity to meet customer schedules while promoting product quality, process efficiency and control Key Requirements: 4/26/2015 38 Bachelors Degree and appropriate continuing education 5 + years experience in a medical manufacturing management role Experience in a ISO 13485 environment Demonstrated leadership skills. Ability to direct and develop a team Adept at managing multiple tasks, prioritize and work with others Ability to analyze, understand and effectively communicate technical information. Excellent written and verbal communication skills ********************************************************************************* Apply for job at https://dell.taleo.net/careersection/2/jobdetail.ftl?job=1002682&lang=en Dell Customer Solutions Executive Healthcare and Life Sciences: Life Sciences (Remote, San Francisco CA) Job ID: 22658645 Position Title: Dell Customer Solutions Executive Healthcare and Life Sciences: Life Sciences (Remote, San Francisco CA) Posted: Company Name: Dell, Inc. Entry Level: Location(s): California, United States March 15, 2015 Job Function: Other No Job Description Job Description Dell Customer Solutions Executive Healthcare and Life Sciences: Life Sciences (Remote, San Francisco CA)-150006OY Dell, Inc. is a worldwide provider of information technology services and business solutions to a broad range of clients. We are currently looking for a Customer Solutions Engineer to join our Enterprise Solutions team covering Large Commercial and Healthcare/Life Sciences accounts in theSan Francisco territory. We seek men and women who share our values, thrive in a team environment, and recognize the importance of accountability; people who strive to exceed expectations to ensure our Clients' success. The Customer Solutions Executive ("CSE") is a senior pre-sales Engineering role requiring significant diverse skills and experiences within IT. The person in this role strives to be a partner with the CTO/CIO, and is a subject matter expert at aligning IT to business needs. The Solutions Executive is the lead architect for designing the exact right solution that will likely encompass all Dell lines of business as well as applications, middleware, and Dell partner products. Dell's Healthcare and Life Sciences organization supports 1,000s of healthcare providers, health plans, pharmaceutical, biotech, medical device, diagnostic and scientific instrumentation customers worldwide. For more than 25 years, Dell has played a critical role in transforming computing, enabling more affordable and more pervasive access to technology around the world. When it comes to Healthcare, with the level of commitment and focus that Michael Dell has brought in the past 2 years, we have gone through a major transformation from a predominantly hardware player to an end-to-end solution provider. In 2009 we made the first Healthcare specific acquisition of Perot Systems. Since then we have acquired 8 companies including InSite One, SecureWorks, Compellent and Boomi. As a result of our continued commitment and focus on healthcare, we have been ranked #1 in Healthcare IT services by Gartner (now 2 years in a row). More than 50% of the US hospitals are our customers including 15 of the top 25 health systems 4/26/2015 39 Role Responsibilities Develop strategy around different solutions: Business Intelligence & Analytics, Big Data, and Information Management Involved in process/team to sell multiple Lines of Business and/or high-end services (e.g. managed / professional services) across multiple industries Involved in process/team to sell primarily enterprise products and managed services with additional sale of computers, printers, peripherals and other hardware Involved in process/team to sell to CEO, CIO, CTO, etc. and may sell to purchasing groups or other decision-making authorities Anticipates how market and competitive factors will influence the selling of Dell products and services Effectively exercises power and influences key decisions for the benefit of Dell and the customer Verifies operability of highly complex product and service configuration within the customer's environment Synthesizes market and industry data to provide thought leadership to position value of the Dell solution Leverages third-party and/or the Channel to create and position Dell solution Provides counsel across account team in analyzing customer requirements and performing advanced systems integration and providing technical expertise to design and implement solution using breadth of Dell products and services Qualifications Requirements 10+ years of relevant experience (in the IT sector selling enterprise based technology solutions) or equivalent combination of education and work experience Ideal candidate will have worked with customers in complex business environments to devise new and innovative solutions to business challenges The ability to anticipate customer needs beyond existing scope of enterprise/client products and services Proven track record of meeting/exceeding sales quota; experience selling into Fortune 1000 size customers This position will be a home/remote based position and candidate must reside in San Francisco. Preferences Bachelor's degree preferred Extensive experience selling technical solutions in support of medium, large and very large accounts Extensive experience conducting system integration Company Description With more than 100,000 team members globally, we promote an environment that is rooted in the entrepreneurial spirit in which the company was founded. Dell's team members are committed to serving our communities, regularly volunteering for over 1,500 non-profit organizations. The company has also received many accolades from employer of choice to energy conservation. Our team members follow an open approach to technology innovation and believe that technology is essential for human success. Why work with us? Life at Dell means collaborating with dedicated professionals with a passion for technology. When we see something that could be improved, we get to work inventing the solution. Our people demonstrate our winning culture through positive and meaningful relationships. We invest in our people and offer a series of programs that enables them to pursue a career that fulfills their potential. Our team members' health and wellness is our priority as well as rewarding them for their hard work. 4/26/2015 40 Dell is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of Any Kind: Dell is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Dell are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Dell will not tolerate discrimination or harassment based on any of these characteristics. Dell is an Equal Opportunity Employer. To learn more about our commitment to Diversity & Inclusion, visit:Equal Employment Opportunity Policy Statement Life at Dell Learn about Dell culture, the interviewing process and benefits offered in your location:Life at Dell Equal Opportunity Employer/Minorities/Women/Veterans/Disabled Job Outside Sales - Sales Engineering Primary Location North America-US-California Other Locations North America-United States Shift Day Job ************************************************************************* ************************************************************************* Other Information for Those in Transition ************************************************************************* *********************************************************************** 32 Biotech and Pharma Recruiters at Source: http://www.genengnews.com/insight-and-intelligence/32biotech-and-biopharma-recruiters/77900088/?page=1 ************************************************************************ 4 Expert Tips on Writing a Resume for Biotech Industry, Nov 25, 2013 by Clinovo Read at http://blog.clinovo.com/4-expert-tips-on-writing-a-resume-for-the-biotech-industry/ See article entitled “6 Ways to Crack the Hidden Job Market” about cracking the hidden job market where 80% of jobs are found. The article was written by Nancy Collamer, M.S., is a career coach, speaker and author of Second-Act Careers: 50+ Ways to Profit From Your Passions During Semi-Retirement. Her website isMyLifestyleCareer.com; on Twitter she is @NancyCollamer. http://www.forbes.com/sites/nextavenue/2013/08/12/6-ways-to-crack-the-hidden-job-market/2/ ******************************************************************** Nice piece on informational interviews by Susan Oct. 22, 2012 at Work Coach Cafe at http://www.workcoachcafe.com/2012/10/22/how-to-do-successful-information-interviews/ Thanks to Paula Rutledge for sharing. ***************************************************************** Check out the annual Beyond Borders: Global biotechnology report 2012 on the biotechnology industry at www.ey.com. This is the 26th anniversary issue using consistent measures to track the industry sector. http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf See Beyond Borders Matters of Evidence 2013 biotechnology report at http://www.ey.com/Publication/vwLUAssets/Beyond_borders/$FILE/Beyond_borders.pdf 4/26/2015 41 See most recent Beyond borders: unlocking value Global biotechnology report 2014 At http://www.ey.com/GL/en/Industries/Life-Sciences/EY-beyond-borders-unlocking-value *************************************************************** Check out the CHI.org website for the most recent publications on the status and trends of the California Biomedical Industry and workforce. These reports were prepared by leading organizations that research the market and lobby for the industry-- PWC, CHI and BayBio. They contain useful information for individuals as well as companies in researching the industry here locally. See 2013 report authored by CHI, PWC and BayBio at http://www.californiabiomedreport.com/ ******************************************************* Writing Resumes UC Davis Internship and Career Center Guide to Resumes (2011) Download at http://iccweb.ucdavis.edu/pdf/crm/0910/crm-resumes.pdf _____________________________________________________________ NOVA workboard releases a report that is of interest to those looking for new opportunities-- Tech Resumes 2.0, an Employer Perspective Silicon Valley in Transition: Tech Job Growth Poses Both Opportunities and Challenges for the ValleyBased on 250 employer surveys and over 50 executive interviews. As a portion of that effort, NOVA released a 2nd report: “Silicon Valley in Transition: Economic and Workforce Implications in the Age of iPads, Android Apps and the Social Web.” It proposes a number of recommendations for better preparing and connecting job seekers with available employment opportunities and for Silicon Valley to maintain its dominance as the world’s preeminent innovation factory. Tech resumes 2.0, an Employer Perspective - The study includes resume advice from 27 Valley recruiters and hiring decision makers as well as practical employment search and resume tips, key messages for job seekers, employers, economic development leaders, educators, and workforce boards. A link to the report is http://goo.gl/uXTX7 ______________________________________________________________ Susan Caldwell wrote an article regarding writing a resume as well. “10 Tips for Creating a Door-Opening Resume” by Susan E Caldwell If you're a medical writer, how can you make sure that you still have work in these tough economic times? Important for staff and freelancers alike, marketing your name and abilities can be done in many ways. One way is to develop and maintain a living resume that speaks to the best you have to offer employers. As an experienced worker, you likely have a professional reputation. Maybe it's good, or maybe it's not so good. How can you enhance or improve your resume so that your best shines through? Here are a few suggestions: 1. Resume Format. Your resume's format should be simple and pleasing to the eye. Because resumes are often input into databases, the simpler the format, the better. Using a simple format should help avoid the need to reformat before your resume is uploaded into a database. When you submit your resume to a recruiter or job board, you should submit it as a Microsoft Word file, but without special formatting. Avoid bullets, bolding, italics, indents, and other formatting that are lost in plain text files. If you do use special formatting, your resume may look like alphabet soup after it's put in a database. Organize your resume in sections, each with a heading that tells the reader what is in that section. Here are some sections typically found in resumes and their approximate order of appearance: Introduction or Career Goal Summary Work History or Professional Accomplishments (if candidate has work history) Academic Background Skills Honors and Awards Publications 4/26/2015 42 There are many variations on the organization and section labels listed above, and you should use what is appropriate for your career stage. Points 7-10 (below) specifically address what content should be included in some of your resume's major sections. When you are ready to format your resume, consider looking at the many examples of resumes available online. Seeing the structures of other resumes may help you decide on your own resume's format and organization. 2. Job Targeting. Decide what your target job or assignment is, and tailor your resume to that job. How do you do that? For one thing, you can pepper your resume with the key concepts, terms, and abbreviations for your target job in your resume; this will show that you know the language in that field. Examples include the terms ICH Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target your resume is to rewrite portions of your resume to match the target job description. This strategy sounds like a lot of work, but it can pay huge dividends. When you submit a targeted resume, it's more likely you will be considered a great match for the position. 3. Resume Emphasis. Emphasize your best accomplishments (for example, an approved eCTD submission that you worked on). Make it clear that you got the job done in an effective way, particularly if it saved time or money. You can do this by positioning these stellar achievements toward the resume's front, writing more about those accomplishments, and/or including specific comments about them in your resume. If there's a web site or information on the web that illustrates or supplements information about your accomplishment, link that information to your resume. 4. Lying on Your Resume. This one is simple: don't lie on your resume. It's a bad idea for several reasons. Not only is it wrong, but if you exaggerate or lie, you may be in over your head if you do get the job. In addition, employers do check resume facts, and they are likely to identify any lies or inconsistencies. 5. Errors in Your Resume. If you're seeking a new job or contract assignment, your resume should be flawless. That is, it should have no typos, misspellings, incorrect grammar, or other writing errors. If you want to open the door to a job interview, show the reader that you are careful about your writing. As a medical writer, the writing that appears in your resume will be the first writing sample an employer sees. Be sure that it will stand up to scrutiny. 6. Resume as Living Document. Ensure that your resume is always current and well crafted; it should be a living document. Update it every time you have new material to add to it. Again, the resume's purpose is to get your foot in the door for an interview. If you don't keep your resume current, you may miss a chance to include vital information, especially if you need it on short notice. For this reason, you should always be ready to send your resume to recruiters or employers on a moment's notice. The remaining points in this article address issues within your resume's sections: 7. Summary. At the start of your resume, include a short (usually 1 to 2 paragraphs) thumbnail summary of your work experience and academic background. It's also appropriate to have a statement that tells the reader what you want to do in your next job. 8. Academic Background. The academic background section should include your earned degrees, the name of the institution where you earned the degree, and the dates when they were conferred. If you have earned an advanced degree, this section may be a good place to list the title of your thesis or dissertation, if any. (Alternatively, your dissertation's citation can be included in your resume's Publications section.) A separate section following your academic background can include the continuing education and training courses you've taken. The list should include the subject matter (or course title) and date(s) when you had the training. And here's an important tip: whenever possible, include specific dates for the education and training. The dates add to your credibility, and their absence can be conspicuous. 4/26/2015 43 As you advance in your career, your academic background generally becomes less important than your work history. After you have a work history, especially in medical writing, consider moving the academic background information in your resume to a location following your work history. 9. Work History or Professional Achievements. In this section of your resume, include specific details about your work history. The reverse chronological work history format often works well, with your most recent job listed first. The work history section should describe your milestone accomplishments for each job or contract assignment. As with the academic background section, include the start and stop dates for the jobs and/or contract work that you've done. The dates will give you added credibility. 10. Publications. If you've authored any publications, put a list of them in your resume with the full citations in a consistent reference format. For publications with multiple authors, you should include all of the authors' names in the order that they appeared in the publication. Finally, try to get access to electronic copies of your publications on the internet. Consider hyperlinking those citations in your resume to the actual articles. In so doing, your reader can easily find and read examples of your work. You can also prepare a set of publication samples as a zipped file to provide to prospective employers. Done well, your resume will open many doors for you, including some you may want to walk through. There are many resources on the internet that will help you create an excellent resume. Take the time to use them, too! You'll be glad you did. About the Author Susan Caldwell is a medical writer, PhD scientist, and entrepreneur. After 10 years of laboratory research, she made a major career course correction and never looked back. She found she could make a career of doing what she loves--writing--and applied it to her background in biomedical research. Since 1995, she has directed medical writers at five life-science companies, including her company, Biotech Ink, LLC. Her specialty is writing regulatory documents for clinical, preclinical, and manufacturing activities that support the development of biotechnology, pharmaceutical, and medical device products. She also has considerable experience writing book chapters, newsletters, brochures, white papers, web content, and many other document types. Susan has been writing and publishing the Biotech Ink Insider newsletter since October 2008. You can email Susan at [email protected], phone her office (650-286-9300), see her LinkedIn profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account). Copyright 2009 Biotech Ink, LLC. All rights reserved. ___________________________________________________ “Writing Your Career Change Resume- 5 Tips,” Job-Hunt.org…your objective source of job search resources website; this might be helpful for those of you leaving a bench science position to another function inside a life science company. http://www.job-hunt.org/career-change/resume-for-career-change.shtml I googled several questions about writing a resume and was astounded that the different sites with free advice, templates, etc. Of course, some service providers were also listed. I googled Amazon’s top books for job hunters and writing resumes and found a list including one of my favorites What Color Is Your Parachute? 2013: A Practical Manual for Job-Hunters and Career-Changers by Richard N. Bolles. I found this book especially useful in helping me determine what types of job functions I liked best. ************************************************************************ 4 Expert Tips on Writing a Resume for Biotech Industry, Nov 25, 2013 by Clinovo Read at http://blog.clinovo.com/4-expert-tips-on-writing-a-resume-for-the-biotech-industry/ 4/26/2015 44 Free Newsletters to Keep You Informed Check out free newsletters delivered to your email box: • “Biospace’s “Genepool,” “Deals and Dollars,” and “Clinical Focus” • “FierceHealthCare,” “FierceHealthIT,” FiercehealthFinancial”, “FierceHealthPayer,” “FierceEMR,” “FierceBiotech,” “FierceMedicalDevices” and “FiercePharma” • “Drug DiscoveryOnline,” • “IN VIVO Blogspot,” “Pharm Exec blog” • “QMed Daily” (formerly DeviceLink.com) • “PRWeek Healthcare Newsletter” • [email protected] PharmExecBlog.com at http://blog.pharmexec.com/ on the business of pharma http://realendpoints.com/blog/ on pricing and reimbursement Luke Timmerman’s blog on Xconomy. ********************************************************************* Ken Wu advises “I found this article titled, 7 Mistakes Job-Seekers Over 50 Make, via the American Society of Quality (ASQ) daily email update. It's worth reading if you're considering how to reposition your self for the upturn in the job market.” The link; http://internsover40.blogspot.com/2009/09/7-mistakes-job-seekers-over-50make.html?WT.mc_id=EM3965M&WT.dcsvid=1541418993. ************************************************************************* Job Sites There’s a new biotech job site on the BIO website entitled Bio Jobs: The Talent Hub for Biotech at http://jobs.bio.org. You can search for open positions via various parameters. Review my weekly listings for individual recruiters and review their websites where they post jobs. Be sure to join the Bio2Device Group and their Linked In Groups where jobs are posted. There are specialized linked in groups that list jobs in the area of interest to its members. I’m a member of separate linked in groups in marketing and marketing research where I gather jobs for my weekly postings. The most known site for career and job listings is www.biospace.com which focuses on biotech and pharma. There’s website with jobs specific to medical device area at the www.legacymedsearch.com. Darshana Nadkarni posts medtech jobs in the jobs category, in her blog at www.darshanavnadkarni.wordpress.com. For any jobs that interest you, she advises you send resume directly to her at [email protected]. You can look up pharmaceutical jobs in your area by zip code at http://jobs.findpharma.com/careers/jobsearch. They include all functions in pharmaceutical companies. ************************************************************************* Susan E. Caldwell a local medical writer shares some insights into finally mastering touch typing. As writers, we must type to do our work, at least if we're using Microsoft Word or other word processor. Many writers become writers without knowing how to touch type (typing without looking at the keys). Touch typing at 40-60 average words per minute, which is industry standard, is roughly 3 to 4 times faster than you can write by hand. The links below are offered so that you can learn and practice touch typing for free (and they aren't presented in any particular order: 1. http://www.sense-lang.org/typing/ 2. http://play.typeracer.com/ 4/26/2015 45 3. http://10-fast-fingers.com/ 4. http://www.learn2type.com/ 5. http://www.touch-typing-tutor.com/ 6. http://www.nimblefingers.com/ 7. http://www.alfatyping.com/ 8. http://www.typeonline.co.uk/typingspeed.php ************************************************************************* Salary Surveys See most recent life scientist salary survey from The Scientist at http://www.the-scientist.com/?articles.view/articleNo/38033/title/2013-Life-Sciences-Salary-Survey/ Contract Pharma publishes an annual salary survey for employees of contract manufacturing companies. The fifteenth survey is available at http://www.contractpharma.com/contents/view_salary-survey/201406-05/2014-fifteenth-annual-salary-and-job-satisfaction-/ The most recent salary survey in medtech is “Medtech Salary Survey 2013: A Sneak Peek” by Jamie Hartford, posted in Medical Device Business, Nov. 5, 2013. See snapshot at http://www.mddionline.com/article/medtech-salary-survey-2013-sneak-peek See additional comments in report dated Nov. 27, 2013. This year’s annual Medical, Marketing and Media salary survey was released in October 2014. The article entitled “Career and Salary Survey: In Check,” Oct. 2014 is found at http://editiondigital.net/publication/frame.php?i=226938&p=&pn=&ver=flex You can download the Premium Edition in pdf at http://media.mmmonline.com/documents/93/css_2014_premium_edition_23196.pdf ************************************************************************* Given the current economic climate, this is a wonderful time to prepare for a career transition and to reassess your career path so that it is aligned with your personal and professional goals. Career Opportunities in Biotechnology and Drug Development, www.careersbiotech.com, published by Cold Spring Harbor Laboratory Press, is a comprehensive, in-depth exploration into the many careers found in the life sciences industry (biotech, pharma and medical devices), based on interviews with over 200 industry executives. It covers 20 vocational areas and over 100 careers. The book was written with the goal of helping readers identify career areas that best suit their interests, values, skills and goals. Each chapter explores the many in-depth nuances of each vocational area. Additionally, there are chapters on resume preparation, job search strategies, informational interviewing and more. A free sample chapter on careers in Project Management is available at www.careersbiotech.com. This insightful and extremely helpful book was researched and written by Toby Beth Freedman, Ph.D., President, Synapsis Search (www.synapsissearch.com) and local guru on life science careers. Toby freely shares her experiences acquired as a researcher, business development manager, recruiter and her indepth research with local industry organizations, such as, local AWIS, the Bio2Device Group and universities. The target audience for this book is people working in academia or in industry who are considering a career transition. It has a broad appeal to scientists, doctors, nurses, lawyers, engineers, business executives, high tech professionals, etc. The book is available on Amazon and a paperback version will be available soon. ************************************************************************* These job postings are listed on my blog accessed at www.audreysnetwork.com/blog along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at [email protected] if they wish to receive these mailings directly. ************************************************************************* 4/26/2015 46
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