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Senior Scientist

4 months ago

Lansdale, United States Insight Global Full time

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