Hi Network!
One of our clients based in the Bay Area is looking for a Manufacturing Project Manager who has experience in the Ophthalmology industry.
The successful candidate will execute the following responsibilities:
- Lead CMC project management activities for a late-stage AAV gene therapy program, ensuring alignment with development and commercialization objectives.
- Provide strategic oversight of CDMO partners to support successful technology transfer, process development, and manufacturing operations.
- Coordinate cross-functional teams across Process Development (PD), Analytical Development (AD), Quality Control (QC), and Manufacturing Sciences & Technology (MS&T).
- Drive accountability, collaboration, and execution of key project milestones and deliverables.
- Develop and maintain integrated project plans, timelines, and risk mitigation strategies.
- Oversee process characterization, validation, and readiness activities to support commercial manufacturing.
- Ensure effective communication and alignment between internal stakeholders and external manufacturing partners.
- Support BLA preparation and submission activities through coordination of CMC deliverables and documentation.
- Evaluate technical, operational, and regulatory inputs to facilitate informed decision-making and program advancement.
- Lead commercial readiness initiatives, ensuring manufacturing processes, quality systems, and regulatory requirements are met for successful product launch.
Please send me your updated resume if you have the experience mentioned above.
Thanks.
