- B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field
- 6+ years experience within vaccine development
- Experience with small, lab, or pilot scale microbial large molecule fermentation
- Biosafety Level 2 exposure (BSL2)
- Experience with bioreactors (20L or 250 ambr)
- Upstream process experience
- Experience with Quality by Design (QbD) and Lean Six Sigma principles
- Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA)
- Leading microbial process development activities to execute large molecule upstream processing including lab-scale process development and process scale-up/scale-down.
- Executing lab scale experiments and authoring associated technical reports and documents.
- Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner.
- Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure.
- Collaborating with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing, both within our Company's network and at contract manufacturing organizations (CMOs).
- Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner.
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Senior Scientist - Lansdale, United States - Insight Global
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Job Description
The Vaccine Process Development and Commercialization (VPDC) group within our Company's Manufacturing Division focuses on late stage process development, technology transfer, and in-line support of vaccine products (live-attenuated vaccines, inactivated vaccines, subunit, recombinant, polysaccharide, and conjugate vaccines). We are committed to keeping pace with the ever-evolving infectious disease landscape by researching and developing vaccine candidates for important diseases. We seeking a Senior Scientist, specializing in fermentation support, BSL 2, & small scale bioreactors -- 20L or Ambr 250mL, with strong scientific and technical skills to lead the development and commercialization activities supporting multiple vaccine programs in late stage development. This is a one and half year long project, with potential extensions.
Responsibilities: