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Peng JiaoCEO, Boston Institute of Biotechnology
About the job
The Director/Associate Director, Upstream Process Development, will lead a team of upstream scientists and associates to develop, optimize and scale up microbial fermentation and mammalian cell culture processes for biologics (recombinant therapeutic proteins) production and support subsequent clinical and/or commercial GMP manufacturing. As a core member of the Biopharmaceutical Development management team, the director will be responsible for the strategic planning and growth of upstream functions.
Responsibilities
- Lead upstream team to develop, optimize and scale up microbial or mammalian upstream processes and primary recovery for biologics production
- Oversee process scale-up, scale-down and late-phase process characterization/validation using QbD approach
- Manage process/technology transfer (externally from client or internally to Manufacturing), and provide manufacturing support and troubleshooting
- Support IND/BLA CMC upstream process document preparation
- Direct upstream innovation projects, new technology evaluation / implementation, as well as conference presentation and journal publication
- Contribute to department and corporate strategic planning and objectives setting
- Mentor team members and manage department budget
- Provide technical support to business and sales team and represent upstream development functions in client meeting
Qualifications
- BS, MS or PhD degree in Biochemical Engineering or related fields
- BS with a minimum of 18+ years, MS with 16+ years, and PhD with 12+ years of upstream process development, tech transfer and/or manufacturing experience
- Strong background in mammalian cell culture (CHO, HEK293), microbial fermentation (E. coli, Pichia pastoris) process development, optimization and scale-up/down
- Strong background in mammalian and microbial process primary recovery (centrifugation, depth filtration) optimization and scale-up/down
- Extensive experience in biologics (mAbs, recombinant proteins, vaccines) late-phase process characterization, tech transfer, manufacturing support and troubleshooting
- Strong knowledge in PAT technologies, GMP / ICH guidelines and CMC experience
- Advanced cross-functional communication, written and presentation skills
- Effective organizational and staff management skills
- Proficient in statistical design of experiment and data analysis using JMP, Minitab, or Design Expert software.
- Flexible and results oriented
