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Associate Director/Director – Upstream Process Development

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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
Staff
50
Projects Completed
130
Years of Experience
20
Growth YoY
247

Apply Now

Please email your resume and why you believe you are a good fit for this position directly to contactus@bostonbib.com Thank you!

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