The Associate Director/Director position is responsible for leading the upstream process development of biological products. The incumbent in this role is a team leader who functions independently, leads, and supports a wide variety of drug development projects including antibodies and proteins.
- Lead and motivate team consisting of associate through senior scientists, process engineers, and process managers.
- Independently plan and lead the execution of upstream process development for assets in all stages of the development lifecycle
- Lead cross-functional drug substance development teams
- Build aligned drug substance project plans across drug substance functions including Cell Line and Banking Development, Upstream Development, Purification Development, BioProcess Engineering, and Drug Substance Manufacturing Biologics.
- Lead projects to develop and implement industry leading cell culture production technologies and platforms.
- She/he will apply cell culture fundamentals and engineering principles to develop, optimize, scale-up, and transfer the upstream manufacturing processes
- Direct management experience leading teams and working cross functionally with related teams
- Experience developing processes for single use and stainless steel bioreactors and working knowledge of cGMP requirements.
- Experience in the biotech/pharmaceutical industry within a mammalian cell culture role and an excellent understanding of the theory and practice of cell culture process development.
- Hands on experience with mammalian cells and biologic products.