Company Information About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands - Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.
Job Description Job Title:
Scientist I, Bulk Formulations
Reports To: Manufacturing Value Stream Manager
Career Band: 4
Job Track: Professional
Position Location: Fremont
Number of Direct Reports: N/A
Day/Shift (if applicable): Day
FLSA Status (Exempt/Non-Exempt): Exempt Position Summary:
Manufactures products for the Toxicology 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. Key Responsibilities:
- Manufacture drugs of abuse immunoassay 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 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 OOSs, 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.
Non-Negotiable Hiring Criteria:
- 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.
- IVD manufacturing experience is a plus
- Laboratory skills and knowledge of safety precautions is a plus
- Experience in working with potentially hazardous chemicals and human source materials is a plus
- Familiarity with Quality System Regulations and ISO 13485 regulations is a plus
- Must be able to lift 25 lbs routinely
- 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
Posting ID: 593557681Posted: 2020-12-31