• Job Description

  Req#: R-01325575

  Work Schedule

  Standard (Mon-Fri)

  Environmental Conditions

  Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

  Job Description

  Position Summary:
  Manufactures products for the Bulk Formulations Toxicology team and completes associated cGMP documentation. Works with chemicals and biologicals to manufacture reagents, calibrators, and controls for IVD immunoassay use. Participates in projects to drive process improvements.

  Key Responsibilities:

  • Manufacture products including reagents, calibrators, buffers, controls, etc. and complete batch records while maintaining cGMPs and GDP standards.
  • Perform in-process testing using clinical analyzers and analyze raw data for in-process adjustments and product release.
  • Review other manufacturing operators/scientist’s batch records.
  • Maintain and analyzes lot histories for trends and discrepancies.
  • Perform laboratory activities including Weighing, transferring, and mixing required chemicals and performing product filtration.
  • Participate in process improvement projects to improve operational efficiencies and support business needs.
  • May modify SOPs, work instructions and reports with mentorship.
  • Initiate and support investigations for quality documentation including NCARS, CAPAs, and Variances.
  • Maintain and troubleshoot testing and formulations equipment as appropriate.
  • Keep department supervisor and/or manager updated on all issues
  • Perform other job duties as the need arises.

  Minimum Requirements/Qualifications:

  • BS/BA in scientific field (Chemistry or Biochemistry preferred) with 0-2 years related experience and/or training preferred. Equivalent combination of education and years of related experience may be substituted.
  • Must be able to lift 25 lbs routinely

  Preferred Hiring Criteria:

  • Must be organized and detail oriented to prioritize own and other’s work and meet business efficiency metrics with great time-management skills!
  • Self-sufficient, self-motivated, and focused
  • IVD immunoassay manufacturing experience preferred
  • General laboratory skills and knowledge of safety precautions preferred
  • Experience in working with potentially hazardous chemicals and human source materials preferred
  • Familiarity with Quality System Regulations and ISO 13485 regulations is a plus
  • Be eligible to handle DEA controlled substances

  Compensation and Benefits

  The salary range estimated for this position based in California is $68,640.00–$95,750.00.

  This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs

  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement

  • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

  • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

  For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

• About the company

  Thermo Fisher Scientific is an American provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.

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