VP, Process Development
1035 O'Brien Drive Menlo Park, CA 94025
VP, Process Development
This role reports directly to the CTO and will act as a process development expert, making decisions that will impact the current and future science of the Company. The Incumbent is responsible for outlining and communicating the Company’ s PD vision: implementing Product Development, and ensuring that the scientific and technological resources are aligned with the Company’ s business and regulatory needs.
In this role, the VP PD works closely with the executive leadership to ensure that scientific and technological strategies robustly underpin the Company’ s overall strategies. The incumbent is responsible for ensuring PD resources are used efficiently, effectively, compliantly, and securely.
This role requires excellent leadership skills, strategic thinking, strong business acumen, and in depth knowledge of biopharmaceutical/vaccines development. This Incumbent is expected to be well-versed in current process development trends and to be familiar with business concepts that can be applied in a fast-moving technology arena.
- Provide leadership, guidance and support to Process Science and Early Process Development teams
- Identify and establish partnerships with external vendors as needed to provide process development activities that can be outsourced
- Develop and execute a comprehensive strategy to initiate process characterization including process validation-enabling studies
- Use sound scientific and engineering criteria to evaluate manufacturing processes changes as needed for optimization and successful scale-up
- Collaborate on the identification of novel vectors by defining manufacturability assessment criteria and overseeing internal production of novel vector batches
- Represent PD at cross-functional alignment meetings and ensure strong collaborative working relationships with Manufacturing, Analytical Development, Quality, etc.
- Represent process development to LT, Board, and external stakeholders, preparing materials and presenting as needed
- Act as subject matter expert (SME) for the process changes in drafting, reviewing, and overall supporting regulatory interactions and documentation
- Ph.D. in biochemical engineering, biochemistry, or appropriate technical discipline with 10+ years (MS with 14+ years) of industrial bioprocess development experience
- Experience with both insect and mammalian cell culture, and associated downstream unit operations
- Experience Drug Product development
- At least 10 years of management experience, with at least 5 years experience leading a process development team
- Highly motivated to lead by example and exceed expectations in all aspects of the role
- Extensive knowledge of late-stage process development activities in preparation for process validation and licensure application is required
- Broad experience in cGMP biologics manufacturing and understanding of regulatory guidelines
- Experience in working with AAV-based vector is strongly preferred
- Demonstrated expertise in upstream and/or downstream process development
- Demonstrated knowledge of formulation development and technical issues associated with Drug Product
- Proven technology transfer and scale-up experience
- Demonstrated the ability to lead and to function in a collaborative/team oriented CMC environment
- Ability to communicate effectively and connect with all levels of the organization
- Strong project leadership and resource management skills
- Require excellent written/oral communication