Associate Director, Process Development

AskBio•Durham, NC

3d•Onsite

About The Position

This role is a secondment opportunity at AskBio, available for a time period to be determined by leadership at both Bayer and AskBio, typically ranging from one to two years. This secondment offers a unique chance to broaden experience, expand knowledge, and contribute to AskBio’s mission of advancing gene therapy. The Associate Director, Process Development is a key position in the Cell Line & Process Development team, serving as a subject matter expert (SME) for novel recombinant adeno-associated virus (rAAV) vector platform development. This position evaluates new cell lines in scale-down models, develops end-to-end processes for production and purification with these novel cell substrates, and recommends forward-looking GMP activities based on development data. This position is onsite at the BioPoint, RTP, NC facility, reporting to the VP of Cell Line & Process Development.

Requirements

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

Nice To Haves

PhD in a scientific or engineering discipline
Cell line development for the production of AAV, antibodies or recombinant protein
Strong working knowledge of Benchling, QbD Vision and/or JMP

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
Identifies 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