Director/Sr. Director of Upstream Process Development
The Director/Sr. Director's job is to steer the development of biological products' upstream processes. The person in this position is a team leader who works alone to direct and assist a variety of client drug development projects, such as those involving monoclonal and bispecific antibodies, fusion proteins, and enzymes.
Duties and Responsibilities
- Lead and motivate team consisting of associate through senior scientists, process engineers, and process managers
- Apply knowledge and understanding of mammalian CHO cell lines to support upstream process development for production of development and tox material
- Design, execute, and analyze experimental data for shake flask, and various scale bioreactors (ambr250, bench scale glass bioreactors, 10L to 200L single use bioreactors)
- Lead and support upstream process technology transfer activities internally from Rentschler Biopharma global network sites, externally from clients, and internally to GMP manufacturing
- Apply DOE and other advanced statistical techniques to design experiments related to late-stage development and process characterization
Qualifications
- Years of experience (one of the following):
- A university degree and 12+ years of related experience
- A Master's degree and 8+ years of related experience
- A PhD and 6+ years of related experience
- Experience working at biologics Contract Development Manufacturing Organization (CDMO) or managing CDMOs and CROs is highly preferred
- Proven hands-on experience with mammalian bioreactors is required.
- Experienced in tech transfer of a process from development to manufacturing or between manufacturing sites.
- Demonstrated, in-depth understanding of environmental, metabolic and mechanical factors influencing cell growth, productivity and stability.
Direct Reports
Junior upstream process development scientists
