Sr. Scientist, Upstream Process Development (AAV) Direct Hire MA

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Job ID: 16385 Direct Hire MA

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Gene Therapy start-up here in the Boston/Cambridge area is looking to bring on-board an AAV Specialist (Scientist/Sr. Scientist) to lead upstream process development for the manufacture of AAV-based gene therapies. The ideal candidate for this position is an experienced Scientist/Engineer with a strong background in AAV manufacturing technologies and an excellent track record in gene therapy upstream process development. The successful candidate would have experience in process scale-up, process optimization, and tech transfer for GMP manufacturing.

Responsibilities include but not limited to:

  • Implement and lead upstream process development of AAV production and technical transfer to GMP.
  • Implement and/or develop innovative vector production technologies based on QbD strategies.
  • Develop protocols for vector production in shake flasks, wave bioreactors, and stirred tank bioreactors.
  • Perform monitoring of cell viability/growth and cell culture metabolites from cultures.
  • Develop intellectual property, publishing scientific papers and other tasks related to the company’s scientific and business interests.
  • Provide scientific expertise and guidance in clinical AAV production, development and innovation.
  • Author and review appropriate CMC documents for regulatory filings.
  • Participate in project related teams as a subject matter expert.

Requirements:

  • Minimum PhD in chemical engineering, biology, biochemistry, chemistry, biotechnology, or a related field and a minimum of 3 years of relevant process development experience OR an MS degree in a related field with significant experience will also be considered.
  • Experience in developing HEK293 or similar mammalian cell-based manufacturing platforms is a must. Prior experience with AAV process development and manufacturing is preferred.
  • Proficient with aseptic techniques and the use of shake flasks, wave-based bioreactors, and stirred tank bioreactors at various scales.
  • A background in cGMP, cGLP, regulatory guidelines related to pharmaceutical development, aseptic processing and process validation is a plus.