Related skills
gmp technology transfer biosafety cabinets bioreactors fermentors📋 Description
- Lead DS manufacturing tech transfer and support GMP ops
- Develop quality-engineering methodologies meeting regulatory requirements
- Support manufacturing and CapEx programs incl. upgrades
- Revise batch records and SOPs; maintain Quality System
- Write protocols/reports; contribute to regulatory filings
- Collaborate with cross-functional teams to support product development
🎯 Requirements
- B.S. in Engineering or Physical/Life Science; chemical/mechanical preferred
- 7+ years GMP manufacturing, process development or engineering
- Experience with bioprocesses; fermentors/bioreactors, TFF, chromatography
- Aseptic filling and biosafety cabinets; QA documentation
- Strong technical writing and verbal skills; cross-functional teamwork
🎁 Benefits
- Competitive compensation package
- Flexible PTO, holidays, and parental leave
- Generous healthcare benefits, HSA match, 401k match
- Employer-paid life and disability insurance, pet insurance
- Wellness discounts and more
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