Associate Director, Gene Therapy Process Development

askbio; Durham (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

AskBio Inc. in RTP, NC seeks an Associate Director, Process Development to lead viral vector manufacturing process development, scale-up, and technology transfer. This role reports to the VP and will act as SME for rAAV platform development.

You will mentor scientists, oversee GMP qualifications of cell banks, collaborate with MSAT and CDMOs, develop regulatory documentation, and drive continuous improvements in productivity and cost of goods.

Qualifications

• Master's Degree in science or engineering with at least eight years of relevant experience.
• Experience managing cross-functional teams of Researchers, Scientists and/or Engineers.
• Experience with recombinant AAV and/or extensive experience in biologics employing relevant unit operations.

Responsibilities

• Lead a team of Research Associates and Scientists responsible for developing viral vector manufacturing processes, scale-up, and internal technology transfer.
• Oversee end-to-end platform development for novel rAAV producer cell lines.
• Collaborate cross-functionally with other AskBio teams and CDMOs; develop regulatory documentation.

Skills

Team leadership

Cross-functional leadership

Process development

Statistical optimization

Regulatory documentation

Education

Master's degree in science or engineering

Job description

AskBio Inc. in RTP, NC seeks an Associate Director, Process Development to lead viral vector manufacturing process development, scale-up, and technology transfer. This role reports to the VP and will act as SME for rAAV platform development.

You will mentor scientists, oversee GMP qualifications of cell banks, collaborate with MSAT and CDMOs, develop regulatory documentation, and drive continuous improvements in productivity and cost of goods.