Purification Tech Transfer Specialist Direct Hire MA

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Job ID: 16418 Direct Hire MA

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Exciting Purification Tech Transfer Specialist role with growing Gene Therapy company here in the Waltham, MA area.  Specialist will lead downstream process tech transfer activities for cGMP production of clinical gene therapy candidates. Work with Bioprocess Development team to define process flows, operating parameters, critical raw materials and equipment. Partner with external manufacturing team to determine timelines and tech transfer deliverables. Work closely with contract manufacturing organizations (CMOs) to communicate process needs, determine facility fit, review documentation, and provide on-floor technical support and post-production review. Includes occasional travel to US-based CMOs.  Responsibilities include but limited to:

  • Apply scientific concepts to the scale-up and scale-down of gene therapy production processes.
  • Generation of downstream manufacturing process descriptions based on bench-scale and pilot-scale data. Contribute to the generation to manufacturing bill of materials.
  • Act as primary bioprocess development downstream contact for CMOs with regard to process transfer, MBR generation/review, and post-production review.
  • Provide on-floor manufacturing support as downstream subject matter expert.
  • Review and trend process data against historical cGMP and BPD data, contribute to campaign summary reports.

Requirements:

  • Bachelor’s or Master’s Degree in Biochemistry, Biology, Chemical/Bio-engineering or other related scientific discipline with 7+ years of biopharmaceutical experience.
  • Downstream processing experience (single-use technology) at bench, pilot or manufacturing-scale.
  • Knowledge of clarification and TFF technologies.
  • Ability and desire to work in a fast-paced, start-up environment
  • Strong collaboration and team-working skills
  • Some Domestic Travel Required Occasionally