CMC Project Manager
San Mateo Metro Area, CA
- Develop and manage integrated CMC timelines across all Research and Development projects. This includes timelines for activities to support Vector Development, Process Development, Analytical Development, Process Transfer (to CMOs), Quality Control and Manufacturing (Drug Substance, Drug Product Fill/Finish and packaging).
- Work with the CMC Technical leads to drive holistic CMC ownership across the product life cycle and to ensure all CMC team deliverables and activities are aligned with all teams, departments and facilitate communication to ensure clarity.
- Manage the CMC team deliverables, scope, timelines, resources on project activities so the program remains within budget, on schedule, and within scope and identify and analyze project risks and help guide teams to develop appropriate mitigation strategies.
- Coordinate and facilitate CMC team meetings (regularly scheduled and ad hoc) by providing meeting agendas, minutes and tracking action items.
- Develop and provide consistent project reporting to the CMC and Project Teams and CMC Project status reporting to Senior Management.
- Provide PM support to coordinate and manage CMO activities (Tech Transfer and GMP Manufacturing support), as the CMC team s primary point of contact.
- Work with the Regulatory Department to develop timelines to support CMC submissions (e.g., INDs and BLAs) and provide structure and leadership to ensure all CMC sections of regulatory submissions are of high quality and completed on-time.
- 3+ years of industry experience in the development of biologic products.
- Strong Project Management experience managing CMC development programs for gene therapy or protein biologic programs.
- Experience in the generation of regulatory filings (INDs and BLAs).
- Strong leadership and communication skills.
- BS/MS/PhD in Biological Sciences or Engineering
- 5+ years of industry experience in the development of Gene Therapy products.
- Strong technical acumen; background in Process and Analytical Development, Process Transfer, GMP Manufacturing or related technical experience strongly preferred.
- Record of successful regulatory filings (INDs and BLAs).