Director, Pre-Clinical Biomanufacturing & Process Excellence

AskBio Inc.; United States; On-site; USD 240,000 - 320,000; Full time

Job summary

AskBio Inc. seeks a Director of Pre-Clinical Manufacturing to lead the RTP facility's PCM team. You will translate the R&D portfolio into scalable manufacturing plans, manage multi-program schedules, and optimize plasmid and rAAV production processes.

You will mentor staff, drive operational excellence, and partner with QA to meet quality and regulatory standards while supporting IND‑enabling GMP production for gene therapies.

Qualifications

• Bachelor’s degree in Chemical Engineering, Biochemistry, Biology or a relevant scientific or engineering discipline.
• Significant hands-on experience in industrial pharma/biotech manufacturing.
• Strong leadership and team-building capabilities.
• Experience with GMP quality systems is preferred.

Responsibilities

• Translate R&D portfolio into a coherent manufacturing strategy with material needs, production pathways, capacity, and priorities.
• Manage pipeline demand and convert into feasible production schedules across programs.
• Oversee plasmid and rAAV production, purification, and quality attributes.
• Lead a cross-functional PCM team to improve cost-effectiveness and operations.
• Develop procedures and documentation to support scale-up and regulatory readiness.

Skills

Leadership

Team management

Communication

Attention to detail

Project planning

Cross-functional collaboration

Education

Bachelor’s degree in Chemical Eng./Biochem/Biology

Advanced degree preferred

Tools

JMP

R

Job description

AskBio Inc. seeks a Director of Pre-Clinical Manufacturing to lead the RTP facility's PCM team. You will translate the R&D portfolio into scalable manufacturing plans, manage multi-program schedules, and optimize plasmid and rAAV production processes.

You will mentor staff, drive operational excellence, and partner with QA to meet quality and regulatory standards while supporting IND‑enabling GMP production for gene therapies.