Process Development Lead, AAV Gene Therapy

Asklepios BioPharmaceutical, Inc. (AskBio); North Carolina; On-site; USD 150,000 - 210,000; 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 tech transfer with novel rAAV producer cell lines. This onsite role reports to the VP of Cell Line & Process Development.

You will mentor teams, collaborate with MSAT on lifecycle management, develop regulatory submissions, and drive improvements in productivity, quality and cost of goods across programs.

Qualifications

• Master’s degree in a scientific or engineering discipline required; 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; knowledge of unit operations.
• Strong understanding of mammalian cell biology and engineering principles.
• DOEs and QbD approaches as part of development strategy.
• Excellent written and verbal communication skills.

Responsibilities

• Lead a team of researchers and scientists for viral vector process development, scale-up, and tech transfer.
• Oversee end-to-end platform development for novel rAAV producer cell lines; apply DOE/QbD to optimize processes.
• Collaborate with MSAT on lifecycle management of clinical program manufacturing.
• Develop internal transfer documents and contribute to regulatory submissions.
• Mentor staff and foster growth; present data at internal and external venues.

Skills

DOE

QbD

Cross-functional leadership

Mammalian cell biology

Education

Master’s Degree in a scientific or engineering discipline

PhD in a scientific or engineering discipline

Tools

Benchling

QbD Vision

JMP

Microsoft Office

Job description

AskBio Inc. in RTP, NC seeks an Associate Director, Process Development to lead viral vector manufacturing process development, scale-up and tech transfer with novel rAAV producer cell lines. This onsite role reports to the VP of Cell Line & Process Development.

You will mentor teams, collaborate with MSAT on lifecycle management, develop regulatory submissions, and drive improvements in productivity, quality and cost of goods across programs.