R&D Manufacturing Scientist III

Full Time @Thermo Fisher Scientific Inc. posted 1 year ago

Job Description

How will you make an impact?

The Scientist I, Formulations is responsible for manufacturing products for the Bulk Formulations team and completes associated cGMP documentation. Works with chemicals and biologicals to manufacture reagents, calibrators and controls for IVD use. Participates in process improvement projects.

What will you do?

  • Manufacture reagents and buffers following cGMPS
  • Perform in-process testing using clinical analyzers. Review and analyze data.
  • Review other manufacturing operators/scientist’s batch records.
  • Maintain and analyzes lot histories for trends and discrepancies.
  • Weigh, transfer, and mix required chemicals
  • Perform product filtrations
  • Participate in process improvement projects to improve efficiencies and support business needs.
  • May modify SOPs, work instructions and reports with guidance.
  • Initiate and support investigations for NCARS, CAPAs, and Variances
  • Maintain and troubleshoot equipment as appropriate.
  • Keep department supervisor and/or manager updated on all issues
  • Perform other job duties as required.

How will you get here?

  • BS/BA in scientific discipline (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
  • Experience in working with potentially hazardous chemicals and human source materials is a plus
  • Laboratory skills and knowledge of safety precautions is a plus
  • IVD manufacturing experience is a plus

Knowledge, Skills, Abilities

  • Laboratory skills and knowledge of safety precautions is a plus
  • Familiarity with Quality System Regulations and ISO 13485 regulations is a plus
  • Must perform tasks in compliance with GMP, GDP, QSRs, ISO and IVD regulations
  • Strong laboratory skills including pipetting, safety, and hazardous chemical handling
  • Must be organized and detail oriented to be able to prioritize own and other’s work and meet business productivity metrics
  • Self-sufficient, self-motivated, and focused
  • Must be able to lift 25 lbs routinely

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer

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