Position Summary The Associate Director, Process Development is a key position in the Cell Line & Process Development team, liaising between the development arms while 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.
Job 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
Minimum 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
Preferred Education, Experience and Skills- 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
