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Job ID :
66157BR
Location :
US - California - Fremont
:
Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.


How will you make an impact?
The Formulations Scientist will manufacture products for the Bulk Formulations team and complete associated cGMP documentation. Work with chemicals and biologicals to manufacture reagents, calibrators, and controls for IVD use. Contribute to the transfer of new products into Manufacturing from R&D. Participates in process improvement projects.


Key Responsibilities:

  • Manufacture products and complete batch records following cGMPS including reagents, calibrators, buffers, controls, etc.
  • Perform in-process testing using clinical analyzers. Review and analyze data.
  • Review and approve other manufacturing operators/scientist’s batch records.
  • Maintain and analyze lot histories for trends and discrepancies.
  • Weigh, transfer, and mix chemicals as required.
  • Perform product filtrations.
  • As a technical lead, act as a primary trainer for other chemists on equipment and procedures.
  • Initiate process improvement projects such as updating processes and/or equipment to improve efficiencies and support business needs.
  • Write, review and modify SOPs, work instructions and reports.
  • Initiate, evaluate, and support investigations for NCARS, CAPAs, and Variances.
  • Maintain, troubleshoot, and validate equipment as appropriate.
  • Perform ERP transactions for work orders and inventory.
  • Keep department supervisor and/or manager updated on all issues including acting as an operations representative at cross-functional meetings.
  • Drive schedule adherence.
  • Act independently to determine methods and procedures on new assignments.
  • Perform other job duties as required.


Minimum Requirements/Qualifications:

  • BS/BA in scientific discipline (Chemistry or Biochemistry preferred) with 4-5 years related experience and/or training preferred. Equivalent combination of education and years of related experience may be substituted.
  • IVD manufacturing experience is a plus.
  • Strong laboratory skills and knowledge of safety precautions.
  • Experienced in working with potentially hazardous chemicals and human source materials.
  • Familiarity with Quality System Regulations and ISO 13485 regulations.
  • Must be able to lift 25 lbs routinely.
  • May be required to lift up to 50 lbs occasionally.
  • 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.
  • MAS product experience is a plus.


At Thermo Fisher Scientific, each one of our 65,000 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.


Apply today! http://jobs.thermofisher.com


Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.




Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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