AAV Process Development Leader

AskBio Inc.; Durham, Northern (NC, KY); Hybrid; 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 and scale-up. You will manage a team of researchers and engineers, oversee GMP cell banks, and collaborate with MSAT on clinical program lifecycle management.

The role requires a Master’s plus eight years in biologics or AAV process development, with DOEs/QbD expertise and strong communication skills. Onsite at BioPoint, RTP, NC; contact [e-mail] for inquiries.

Qualifications

• Minimum eight years of relevant work experience in a scientific/engineering role.
• Experience managing cross-functional teams of researchers/engineers.
• Experience with recombinant AAV or biologics process development.
• Strong DOEs and QbD know-how and design of experiments experience.
• Excellent written and verbal communication skills; familiarity with regulatory documents.
• Proficient in MS Office and statistical software.

Responsibilities

• Lead a team developing viral vector manufacturing processes and scale-up.
• Manage end-to-end platform development for novel rAAV producer cell lines.
• Oversee GMP cell bank qualifications and critical raw materials.
• Collaborate with MSAT on lifecycle management of clinical programs.
• Develop internal tech transfer documents and regulatory submission sections.
• Present data to colleagues, senior management, and external partners.

Skills

Cross-functional leadership

Design of experiments

Quality by Design

Mammalian cell biology

Statistical analysis software

Microsoft Office

Education

Master’s Degree in scientific/engineering discipline

PhD in scientific/engineering discipline

Tools

Benchling

QbD Vision

JMP

Job description

AskBio Inc. in RTP, NC seeks an Associate Director, Process Development to lead viral vector manufacturing process development and scale-up. You will manage a team of researchers and engineers, oversee GMP cell banks, and collaborate with MSAT on clinical program lifecycle management.

The role requires a Master’s plus eight years in biologics or AAV process development, with DOEs/QbD expertise and strong communication skills. Onsite at BioPoint, RTP, NC; contact [e-mail] for inquiries.