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