Scientist III, Formulation
at Thermo Fisher Scientific
Fremont, CA 94555, USA -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 29 Nov, 2024 | USD 91000 Annual | 01 Sep, 2024 | 2 year(s) or above | Iso,Hazardous Chemicals,Pipetting,Gmp,Laboratory Skills,Regulations,Chemical Handling | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
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 field (biology/biochemistry) with 2-4 years of related experience and/or training preferred. AA degree with 4-6 years of 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 diligent 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 the 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