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Senior Scientist
4 months ago
Must Haves:
- 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
Pluses:
- 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)
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:
- 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.
