The Associate Director, Upstream Process Development is responsible for and leads all elements of the company's AAV gene therapy platform's cell culture process development. This position is in charge of leading cell culture development activities from research to tox and clinical investigations, as well as establishing the strategy for the initial IND, Phase 3, and commercial launch. The manufacturing of research-grade gene therapy materials for characterization and animal testing is also handled through process development.
- Oversee the development of our AAV platform's cell culture methodology. Lead the CCPD team in the development of goals, plans, and performance indicators that are reviewed and reported to the company on a regular basis.
- Lead and direct the CCPD group, as well as manage and coach junior staff.
- Plan and distribute resources in order to achieve organizational goals.
- Develop and manage the cost and capital budgets for the CCPD group.
- Assist in the transition of technology to manufacturing by providing disciplined output to Technical Operations teams.
- Lead a team which has oversight for the cell culture portion of the following activities:
- Process development through IND, late stage clinical and final process validation.
- Manufacture of non-GMP materials for animal and research studies
- Clear communication with the project teams to ensure timely dissemination of information (titers, yields, purity, CPPs, CQAs, etc.) and delivery of materials.
- Generation of technical reports as needed
- Authorship of CMC sections for regulatory submissions
- Provide technical support to manufacturing and CMO
- Keep track of project activity, deliverables, and completion in relation to budgets and corporate goals.
- Assists strategic planning by identifying development scenarios, risks, and alternatives in collaboration with Research, Program Management, Clinical, and internal and external Manufacturing teams.
- Recognizes risks and assumptions in plans, predicts issues, and makes contingency plans. Removes roadblocks in order to move work forward and/or refocus efforts.
- Assesses innovative cell culture technologies that offer advantages in product manufacture and quality assurance.
EDUCATION, EXPERIENCE, AND SKILLS REQUIREMENTS:
- A bachelor's degree in a life science or engineering subject is required, with a PhD desirable.
- At least 8 years of relevant experience in biotechnology or pharmaceuticals. An understanding of gene-based and rAAV-based therapeutics will be advantageous.
- Demonstrated expertise in building cell culture techniques that result in successful regulatory submissions.
- Product licensure experience with late-stage development and process characterization/validation is strongly desirable.
- Experience managing and coaching junior employees is also a plus.
- Knowledge of FDA, ISO, EMA, GMP, and ICH regulations.