Job: Associate Director GMP Process Development - 80191, Duke Human Vaccine Institute, Durham, NC
The Associate Director, GMP Process Development is responsible for planning, organizing and overseeing the activities relating to the development of manufacturing processes and platforms for cGMP manufacturing of clinical vaccine products. They will work closely with the cGMP operations, cell line development, program management and analytical teams to deliver technology platforms suitable for the cGMP manufacture of clinical vaccine candidates. They will provide direct oversight to the GMP Managers of the Upstream and Downstream Process Development, and are accountable for developing resource planning, goals and development targets for these teams.
The Associate Director, GMP Process Development will have relevant knowledge and industrial experience in the field of bioprocess development for manufacture of biomolecules and vaccines and will have experience in transferring processes to cGMP facilities for clinical manufacture, and completing required regulatory submissions. They are expected to possess a high level of skill and experience with developing scalable manufacturing processes across a wide variety of technology platforms such as cell-based, viral -based, and nucleic acid-based therapies. They will also have demonstrated experience in biomolecule (protein, mRNA, DNA) characterization.
• Qualified via experience and technical knowledge to author and be a Principal Investigator in grant and contract proposals. Responsible for planning, organizing and overseeing the activities related to the development of manufacturing processes and platforms for GMP manufacturing products. Work closely with GMP operations, cell line development, program management and analytical teams to deliver technology platforms suitable for GMP manufacture of Phase I clinical candidates. Provide direct oversight of Upstream and Downstream Process Development teams, and develop resource planning, goals and development targets for staff.
• Design and oversee the development strategy to deliver novel vaccine products to the clinic. Manage multiple development teams, budgets and resource planning to deliver the portfolio of programs expected of the DHVI GMP Process Development team.
• Apply innovative solutions using state-of-the-art techniques to develop strategies for efficient and cost effective clinical manufacturing.
• Lead the authoring of regulatory submission sections and meetings with regulators as required.
• Represent GMP Process Development and provide thought leadership for GMP platforms at DHVI leadership and NIH collaborator forums.
• Lead, mentor and develop staff.
• Partner with the QA/QC unit at DHVI to develop a phase appropriate Quality assurance programs to support process development.
• Communicate updates and issues to the Sr. Director of Product Development and other members of the DHVI leadership team as required.
• Direct safe working practices in the facility.
• Ensure a culture of strong GMP compliance
Required Qualifications at this Level
Education/Training: Bachelor's degree in a science, engineering, or related field. Advanced degree MS/PhD is highly preferred.
Experience: 12 years of years of experience in the biopharmaceutical or bioprocess industry or equivalent is required with direct experience in process development. Previous supervisory experience is required.
• A PhD in engineering, biochemistry or directly related scientific field.
• Minimum of 12 years of years of experience in the biopharmaceutical or bioprocess industry is required with direct experience in process development. Previous supervisory experience, experience managing budgets and project portfolios, and Phase I/II regulatory submissions is required.