Senior Bioprocess Engineer

Senior Bioprocess Engineer

Duke Human Vaccine Institute

Role Summary

The Senior Bioprocess Engineer will lead the development, tech transfer, and GMP execution of production processes for innovative vaccine products. This position will be involved in bioprocess development and GMP production, including lab scale process development; scale up and tech transfer of the process into the GMP suite, and execution of the process under GMP compliant conditions.

Responsibilities

• Advise management on strategic direction and focus of technical programs.
• Demonstrate bioprocess innovation and capabilities to develop suitable bioprocesses.
• Use experience in leverage risk assessment to foster understanding and comprehensive collaborative decision making.
• Use knowledge of end to end process for manufacturing, experience working in a CDMO environment, supply chain awareness, technology transfer, authoring draft manufacturing batch records, bill of materials, process flow diagrams, process description documents and collaboration with GMP manufacturing teams.
• Facilitate team data review and discussion at group meetings and larger team settings.
• Lead review of technical development reports; write and review protocols for tech transfer and SOPs for GMP production and present data to project teams and larger settings.

Education and Experience

Bachelor’s degree in science, engineering, or related field. An advanced degree (Master’s, PhD) is preferred. Plus 13 years relevant experience in the biopharmaceutical industry or equivalent.

Required Skills

• Expertise in CHO and mammalian cell culture, suspension bioreactor platforms, process scaling up 3-40-200 L, single use technologies including ambr15 and ambr250, media development, cell line development, cell culture harvest clarification using depth filtration and continuous flow centrifugation and host cell protein reduction during cell culture.
• Experience with phase-I process development, DOE studies, development of process control strategies. Familiarity with JMP or similar statistical software.
• Demonstrate advanced ability to collaboratively solve complex problems aligned with strategic program goals.
• Superior oral and written communication skills.

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