Tessera Therapeutics is an early-stage life sciences company pioneering Gene Writing, a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability.
Tessera Therapeutics is seeking an Associate Director of AAV Cell Culture Process Development. The candidate will provide the technical and operational leadership for development of robust and scalable AAV cell culture processes. This person will oversee a team of scientists and engineers responsible for development and scale-up of the upstream process and technology transfer to the GMP facilities.
- Lead the AAV upstream process development team to development scalable and productive cell culture processes for AAV manufacturing.
- Contribute to the development of in-house AAV production capabilities and to the supply of high quality AAV for pre-clinical and platform development.
- Review experimental plans for screening, optimization, and scale-up efforts for AAV production.
- Develop and qualify reliable scale down models.
- Contribute to selection, tech transfer, and coordination of contract manufacturing organizations (CMOs) for GxP material supply.
- Define technical requirements of the upstream process for implementation at CMO, including equipment specification/selection, draft procedures and recommended operating parameters/ranges, and raw materials definition and preparation.
- Write protocols and technical reports and participate/present to cross-functional teams.
- Build and lead a team of engineers and scientists and support the design, execution, and interpretation of the experimental studies.
- Contribute to establishing the individual and team objectives to maintain project timelines.
- MS with 10+ years or PhD with 6+ years of relevant industrial experience. Degree emphasis in Chemical Engineering, Bioengineering, or Biological Sciences.
- In-depth technical understanding and experience in upstream process development and manufacturing for viral vectors or biologics. A proven track record of AAV cell culture development is strongly preferred.
- Experience with process scale-up and technology transfer to CMOs.
- Experience with high-throughput cell culture process development platforms and statistical design of experiments (DoE) is strongly preferred.
- Experience in working with vendors and partners.
- Experience with process development and Quality by Design (QbD) methodology.
- Knowledge of GMP/ICH/FDA regulations for early-stage viral vector gene therapy programs is strongly preferred.
- A strong self-starter, independent thinker, with a strong attention to details.
- Track record of completing deliverables within specified timelines.
- Excellent communication and presentation skills, capable of conveying technical information in a clear and thorough manner.
- Eager to work with highly skilled and dynamic teams in a fast-paced, entrepreneurial, and technical setting.
- Experience managing multiple direct reports.
More About Flagship Pioneering
Flagship Pioneering conceives, creates, resources, and develops first-in-category life sciences companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $50B in aggregate value. To date, Flagship has deployed over $2.2B in capital toward the founding and growth of its pioneering companies alongside more than $18B of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Axcella Health (NASDAQ: AXLA), Denali Therapeutics (NASDAQ: DNLI), Evelo Biosciences (NASDAQ: EVLO), Foghorn Therapeutics (NASDAQ: FHTX), Indigo Ag, Kaleido Biosciences (NASDAQ: KLDO), Moderna (NASDAQ: MRNA), Rubius Therapeutics (NASDAQ: RUBY), Sana Biotechnology, Seres Therapeutics (NASDAQ: MCRB), and Sigilon Therapeutics (NASDAQ: SGTX).