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.
- 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.