Scientist III, Formulation

at  Thermo Fisher Scientific

Fremont, CA 94555, USA -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate21 Nov, 2024USD 91000 Annual28 Aug, 20242 year(s) or aboveRegulations,Pipetting,Iso,Gmp,Laboratory Skills,Chemical Handling,Hazardous ChemicalsNoNo
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Description:

POSITION SUMMARY:

Manufactures complicated products and completes associated documentation. Contributes to the transfer of new products into Manufacturing. Participates in process improvement projects.

MINIMUM REQUIREMENTS/QUALIFICATIONS:

  • BS/BA in life scientific discipline (biology/biochemistry) with 2-4 years of related experience and/or training preferred. AA degree with 4-6 years related experience may be substituted.
  • Strong lab skills and knowledge of safety precautions.
  • Familiarity with Quality System Regulations and ISO 13485 regulations.
  • Experienced working with potentially hazardous chemicals and human source materials.
  • Must be able to lift 25 lbs routinely.
  • May be required to lift up to 50 lbs occasionally.

KNOWLEDGE, SKILLS & ABILITIES:

  • Must be in compliance with GMP, QSRs, ISO and IVD regulations in the performance of department responsibilities.
  • 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.
  • Must exhibit strong leadership ability.
  • Self sufficient, self-motivated, and focused.

Responsibilities:

  • Manufacture advanced products and complete batch records following all cGMPs.
  • Products include calibrators, controls, buffers, etc.
  • Perform in-process assays using clinical analyzers. Review and analyze data.
  • Weighing, transferring, and mixing of chemicals as required.
  • Perform product filtrations.
  • Review and approve completed batch records.
  • Maintain and analyze lot histories for trends and discrepancies.
  • Analyze data to perform calculations for constituent additions and dilutions.
  • Train junior scientists on equipment and procedures.
  • May write, review, and modify SOPs, work instructions and reports.
  • Maintain, troubleshoot and validate equipment as appropriate.
  • Execute process validations as appropriate.
  • Participate in process improvement projects to improve efficiencies and support business needs.
  • Initiate, evaluate, and draft write ups for NCARs, OOS’s and Variances.
  • Keep department lead or manager updated on all issues.
  • Perform other job duties such as small equipment cleaning and autoclaving of small parts using lab autoclave and washer as required.


REQUIREMENT SUMMARY

Min:2.0Max:6.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Proficient

1

Fremont, CA 94555, USA