Tome Biosciences is the programmable gene insertion company. Using CRISPR, our technologies allow us to insert any genetic sequence of any size at any location into any genome. We are writing the final chapter in genomic medicines, delivering cures to patients through cell and genome engineering.
Our CMC Team is growing! Reporting to our Director, Manufacturing & Process Development, we are seeking an Associate Director, AAV Process Development to join our organization. This position will be responsible for leading an integrated process development team. This position will play a critical role in successfully developing manufacturing processes that deliver a quality product.
- Build and lead an integrated process development team across upstream and downstream functions for viral vector (AAV) production
- Define and execute drug substance development plans that will establish suitable manufacturing processes and control strategies for clinical manufacturing
- Drive process tech transfer to internal and/or external manufacturing teams
- Contribute to regulatory filings through authorship of technical reports and Module 3 sections
- Manage and develop scientists and associates to improve performance and prepare them for future roles
- Identify and act on areas of platform innovation and contribute to Tome’s IP portfolio
- Ph.D. in Chemical/Biomedical Engineering, Biochemistry, or a related discipline with 8+ years of relevant industrial experience, M.S. with 10+ years, or B.S with 12+ years
- Strong technical experience in scalable viral vector production encompassing cell culture and purification by chromatography/filtration
- Experience executing process development activities as part of a successful IND-enabling and/or clinical program
- Extensive knowledge of viral vector process analytics
- Demonstrated ability to hire and develop top scientists/associates
- Strategic thinker with an innovative mindset
- Excellent interpersonal and communication skills (both verbal and written)
- Recognized scientific leadership as evidenced by journal articles, patents, or presentations