Director, Preclinical Manufacturing & Ops

AskBio Inc.; Durham (NC); On-site; USD 180,000 - 260,000; Full time

Job summary

AskBio Inc., a leading gene therapy company, seeks a Director of Pre-Clinical Manufacturing to lead the PCM team at the RTP facility. The role oversees plasmid DNA and rAAV production across multiple programs, with emphasis on scalability, process robustness, and regulatory readiness.

The ideal candidate will bring hands-on bioprocess expertise, leadership of cross-functional teams, and a track record of delivering IND-enabling GMP production strategies in collaboration with R&D, PD, and MSAT.

Qualifications

• Bachelor’s degree in Chemical Engineering, Biochemistry, Biology or related field, 10+ years industry experience.
• Proven leadership managing scientists and associates.
• Experience in biologics manufacturing (mAbs, recombinant proteins, vaccines, or viral vectors).

Responsibilities

• Translate R&D portfolio into a manufacturing strategy and plan.
• Manage pipeline demand into feasible production schedules.
• Lead cell culture, transfection, harvest, purification, and vector quality attributes.
• Oversee lab and supply chain for Pre-Clinical Manufacturing and MSAT teams.
• Collaborate with project management to set timelines and milestones.
• Develop and maintain project documentation and communications.
• Mentor junior staff and manage budgets and cross‑department charges.
• Partner with QA to ensure regulatory alignment and compliance.

Skills

Leadership

Bioprocessing

Cell culture

Project management

Analytical testing

Communication

Quality systems

Education

Bachelor’s degree in Chemical Engineering, Biochemistry, Biology or related

Tools

GMP knowledge

JMP

R

SOPs

Job description

AskBio Inc., a leading gene therapy company, seeks a Director of Pre-Clinical Manufacturing to lead the PCM team at the RTP facility. The role oversees plasmid DNA and rAAV production across multiple programs, with emphasis on scalability, process robustness, and regulatory readiness.

The ideal candidate will bring hands-on bioprocess expertise, leadership of cross-functional teams, and a track record of delivering IND-enabling GMP production strategies in collaboration with R&D, PD, and MSAT.