Associate Director, AAV Process Development

NCBiotech; Durham (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

AskBio Inc. is seeking an Associate Director, Process Development to lead viral vector manufacturing process development and technology transfer for novel rAAV cell lines at the RTP, NC site.

You will partner with MSAT and QA teams to optimize production and implement robust DOEs/QbD strategies. The role requires a Master’s degree with 8+ years in biologics and a proven track record of cross-functional leadership, data-driven decision making, and strong communication skills.

Qualifications

• Master’s Degree in a scientific or engineering discipline with a minimum of eight years of relevant work experience.
• Prior experience managing cross-functional teams of Research Associates, Scientists and/or Engineers.
• Prior experience with recombinant AAV and/or extensive experience in biologics employing relevant unit operations.
• Strong understanding of mammalian cell biology, engineering principles and how to interconnect them.
• Self-motivated leader with a track record of novel development of biologics demonstrated through publications, patents, posters and/or presentations.
• Functional expertise in design of experiments (DOEs) and Quality by Design (QbD) approaches.
• Excellent written and verbal communication skills.
• Good working knowledge of Microsoft Office suite (Word, Outlook, Excel) and statistical analysis software

Responsibilities

• Lead a team of Research Associates and Scientists responsible for developing viral vector manufacturing processes, scale-up, and internal technology transfer.
• Management of end to end platform development for novel rAAV producer cell lines applying statistical approaches for experimental execution and optimization.
• Oversee internal qualifications of GMP cell banks and critical raw materials in vector manufacturing processes.
• Partner with MSAT on life cycle management of clinical program manufacturing and optimization.
• Lead platform fit and/or development activities for portfolio programs, as needed.
• Identify and develop new technologies for increased productivity, recovery, product quality and/or improved cost of goods.
• Collaborate cross-functionally with other AskBio teams inside and outside of Technical Operations, including our partner CDMOs.
• Develop internal tech transfer documents and author/review CMC regulatory documents.
• Review and communicate experimental results both orally and in written reports/presentations to colleagues, senior management and at external partners and conferences.
• Identifes CapEx needs, develops corresponding budget and justification.
• Assists with the development of and adherence to department budgets.
• Identifies and executes against personnel plans, including hiring, training, and development in the pursuit of organizational objectives.
• Contributes to intellectual property strategies and manages staff to successful IP support.
• Author technical and development documents, including relevant sections in regulatory submissions.
• Mentors and develops team members by establishing a collaborative and growth minded culture that encourages personal and professional development.
• Present scientific data at internal forums and external conferences

Skills

Team leadership

Communication

Experimental design

Statistical analysis

Cross-functional collaboration

Education

Master’s degree in science or engineering

PhD (preferred)

Tools

Benchling

QbD Vision

JMP

Microsoft Office

Job description

AskBio Inc. is seeking an Associate Director, Process Development to lead viral vector manufacturing process development and technology transfer for novel rAAV cell lines at the RTP, NC site.

You will partner with MSAT and QA teams to optimize production and implement robust DOEs/QbD strategies. The role requires a Master’s degree with 8+ years in biologics and a proven track record of cross-functional leadership, data-driven decision making, and strong communication skills.