Senior Scientist, Product Support

    • Redwood City, CA

Summary of Major Responsibilities

The Senior Scientist, Product Support role will lead a variety of sustaining product support activities within Operations. This role will investigate issues and troubleshoot materials, processes, and test methods through root cause analysis and then design, develop, and implement corrective actions. This role will also lead Operations teams in process and method development, new product introduction, and continuous improvement.

Essential Duties and Responsibilities

  • Provide leadership in technical product support to Operations by working cross-functionally with Production, Quality Control, Supply Chain, R&D, and Quality Assurance teams.
  • Lead troubleshooting of out-of-specification and non-conforming materials through root cause analysis, experimental design, execution, analysis, and reporting.
  • Provide support to Operations teams for identification and qualification of alternative suppliers and raw materials.
  • Provide leadership for continuous improvement initiatives.
  • Design and execute complex studies and experiments supporting development, troubleshooting, and improvement projects.
  • Generate experimental protocols and work instructions, characterize, and develop test methods, improve procedures, and summarize activities through technical summary or investigative reports.
  • Troubleshoot complex instrumentation; such as plate readers, PCR instruments, and liquid handlers.
  • Trend and track historical production data.
  • Lead and support design of CAPA plans working closely with Quality Assurance.
  • Conduct bench level experiments across product areas to identify problems and justify solutions.
  • Excellent oral and written English communication and presentation skills.
  • Excellent interpersonal skills.
  • Effective analytical, problem solving and decision-making skills.
  • Ability to maintain open communication and collaboration with colleagues, management, and suppliers.
  • Ability to prioritize and adapt to changing priorities while maintaining a high standard of quality.
  • Ability to work and thrive in a fast-paced, multidisciplinary, and dynamic environment.
  • Ability to work on multiple projects simultaneously.
  • Ability to prioritize tasks and adhere to project schedules and timelines.
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
  • Support and comply with the company’s Quality Management System policies and procedures.
  • Regular and reliable attendance.
  • Ability to work designated schedule.
  • Ability to work nights and/or weekends.
  • Ability to lift up to 40 pounds for approximately 2% of a typical working day.
  • Ability to work seated for approximately 50% of a typical working day. Ability to work standing for approximately 50% of a typical working day.
  • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 30% of a typical working day.
  • Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
  • Ability to comply with any applicable personal protective equipment requirements.
  • Ability to use various types of typical laboratory equipment including microscopes, microtomes, blades, strainers, vortexers, heating plates, and pipettes for extended periods of time.
  • May perform repetitious actions using lab tools.
  • Ability and means to travel between Redwood City locations.
  • Ability to travel 10% of working time away from work location, may include overnight/weekend travel.

Qualifications

Minimum Qualifications

  • Master’s degree in Life Sciences, Engineering or related field; or Bachelor’s degree in Life Sciences, Engineering or related field and 2 years of relevant experience in lieu of Master’s degree.
  • 7+ years of experience with in vitro diagnostics or medical devices in a development or technical product support role within Operations.
  • 6+ years of related industry experience.
  • 5+ years of hands-on experience biochemical and molecular biology techniques; including nucleic acid or enzyme-based assays, qPCR, or next generation sequencing assays.
  • 3+ years of experience working in a regulated environment (ISO 13485 or 21 CFR 820).
  • Strong knowledge in basic and advanced continuous improvement methodologies/principles; such as Lean Six Sigma and/or Practical Process Improvements.
  • Strong knowledge of Design for Six Sigma and advanced knowledge of statistical methods in biology; including experience with JMP software.
  • Proficient in a variety of common laboratory skills and techniques in chemistry, biochemistry, and molecular biology.
  • Proficient in Microsoft Office.
  • Basic computer skills to include Internet navigation, Email usage, and word processing.
  • Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
  • Authorization to work in the United States without sponsorship.

Preferred Qualifications

  • 4+ years of experience leading or directing project teams.
  • Experience supporting complex laboratory equipment such as PCR instruments or liquid handling robots.
  • Consistent track record in solving technical problems effectively and efficiently. 

 

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EEO Disclosure

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.


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