Senior Associate Director, AAV Process Development

AskBio Inc.; Durham (NC); On-site; USD 150,000 - 210,000; Full time

Job summary

AskBio Inc. in Research Triangle Park, NC, is seeking an Associate Director, Process Development to lead viral vector manufacturing process development and scale-up.

You will oversee end-to-end platform development for novel rAAV producer cell lines, applying DOE-based optimization and QbD approaches. You will mentor a team of researchers, coordinate cross-functional efforts with MSAT and other groups, and contribute to regulatory documentation and tech transfer.

Qualifications

• Master’s Degree in a scientific or engineering discipline with at least eight years of relevant work experience.
• Experience managing cross-functional teams of Research Associates, Scientists and/or Engineers.
• Experience with recombinant AAV and/or biologics unit operations.
• Strong understanding of mammalian cell biology and engineering principles.
• DOEs and QbD approaches; publications or patents a plus.
• Excellent written and verbal communication; MS Office and stats software.

Responsibilities

• Lead a team of researchers responsible for developing viral vector manufacturing processes and technology transfer.
• Manage end-to-end platform development for novel rAAV producer cell lines using DOE-based optimization.
• Oversee GMP cell banks qualifications and raw materials in vector manufacturing.
• Collaborate with MSAT on life cycle management of clinical program manufacturing.
• Develop internal tech transfer documents and author CMC regulatory submissions.
• Present results to colleagues, senior management and external partners.

Skills

Cross-functional leadership

AAV knowledge

Mammalian cell biology

Design of experiments (DOE)

Quality by Design (QbD)

Scientific communication

Statistical analysis

Education

Master's degree in science/engineering

PhD in science/engineering

Tools

Benchling

QbD Vision

JMP

Microsoft Excel/Office

Job description

AskBio Inc. in Research Triangle Park, NC, is seeking an Associate Director, Process Development to lead viral vector manufacturing process development and scale-up.

You will oversee end-to-end platform development for novel rAAV producer cell lines, applying DOE-based optimization and QbD approaches. You will mentor a team of researchers, coordinate cross-functional efforts with MSAT and other groups, and contribute to regulatory documentation and tech transfer.