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Senior Scientist
1 month ago
Education Minimum Requirement:
- B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 6+ years of relevant experience; or
- Master's degree with 4+ years of relevant experience; or Ph.D. with relevant experience.
Required Experience and Skills:
- Large molecule process development, or relevant experience including scaling (up and down) and tech transfer of large molecule drug substance processes
- Good understanding of microbial physiology and metabolism and ability to correlation to in-lab or shop floor fermentation events
- Experience with small, lab or pilot-scale microbial large molecule fermentation
- Expertise in lab scale experimental execution and experience with statistical data analysis and presentation of results/conclusions.
- Experience with authoring technical documentation.
- Outstanding communication and people skills.
- Current Good Manufacturing Practice (cGMP) experience
Preferred Experience and Skills:
- Knowledgeable in Drug Substance, end-to-end process development, including microbial, live virus vaccine, gene therapy, or oncolytic virus processes.
- Experience with downstream unit operation mathematical modeling, theoretical scaling calculations, computational fluid dynamics (CFD) modeling.
- 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)
- Experience with on-the-floor Good Manufacturing Practice (GMP) manufacturing support including providing immediate responses on the shop floor to deviations and potential deviations
1.5 year contract with possibility to extend - PTO available
Compensation: 45-60/hr
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