Director of Upstream Process Development

City
Durham

State
NC

Job Type
Full-Time Regular

Job Description

Our Client is a fast-growing, Science-Driven and Customer-Focused Life Science Company serving the global biopharmaceutical industry. Their business model is designed from the ground up to help clients accelerate their path to market while reducing risk and building value.

The Company has proven expertise in developing upstream and downstream processes, analytics and formulations, scale-up, technology transfer, and cGMP manufacture of protein-based therapeutics for pre- clinical and clinical manufacturing, process optimization and characterization, process performance qualification, and commercial launch production.

This person will manage 35+ direct reports in the cell culture and harvest of mammalian cell lines (mainly CHO variants) in support of process development, scale-up, and technology transfer to cGMP manufacturing.

  • Serves as a subject matter expert, providing technical oversight to their team, and training to junior scientists. Familiar with functional area interdependencies, including cell culture, purification, analytical, and site readiness.
  • Develops the members of their team (direct reports) through career guidance and mentorship.
  • Provides technical leadership for product development efforts in the process and manufacturing areas. Conceptualizes and proposes process development and manufacturing based on biopharmaceutical data. Has in-depth understanding for data analysis and interpretation of cell culture data.
  • Provide technical support for clinical manufacturing and product testing.
  • Works toward developing a broad knowledge of state of the art scientific principles, theory of cGMP and other regulatory requirements; provide technical leadership in the group, serve as in-house advisor on key scientific discipline areas.
  • Oversees cell culture-specific project plans, including raw materials and equipment availability, in preparation of laboratory and pilot-scale runs from their team.
  • Responsible for producing high quality documentation and client reports suitable for publication and regulatory requirements.
  • Adheres to all safety requirements and assures that departmental employees comply with required safety procedures.

Minimum qualifications:
  • Degree within Chemical Engineering, Biotechnology or related area:
  • Ph.D. with 12+ years’ experience
  • Able to react to change productively and handle other essential tasks as assigned.
  • Subject matter expert in areas of process development, technology transfer, scale-up of processes to pilot and manufacturing scales
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