ProKidney offers treatment of chronic kidney disease (CKD) through innovations in cellular therapy. Backed by North Carolina Biotechnology Center.
About the role
The Director, CMC Project Management will be responsible for managing activities related to CMC Planning. In conjunction with internal subject matter experts and consultants, the Director will be responsible for identifying CMC Gaps and implementing cross functionally aligned CMC strategy to support late stage and commercial CMC regulatory submissions, coordinating the planning and on-time completion of CMC activities through BLA filing, PLI and approval.
What they're looking for
- Education/Training:
- Experience:
- Prior background in CMC project management at a biotech/pharma company focused on biologics/cell & gene therapy
- Experience leading project managers or a project management team
- Skills/Abilities:
- Must have sufficient CMC depth to identify dependencies, risks and gaps across manufacturing, quality, analytical and regulatory activities working with SME’s
More about this role
The Director, CMC Project Management will be responsible for managing activities related to CMC Planning. In conjunction with internal subject matter experts and consultants, the Director will be responsible for identifying CMC Gaps and implementing cross functionally aligned CMC strategy to support late stage and commercial CMC regulatory submissions, coordinating the planning and on-time completion of CMC activities through BLA filing, PLI and approval. The successful candidate must possess a technical understanding of the inter-disciplinary nature of cell therapy development, demonstrated with previous experience. The position requires timeline and deliverable management with close collaboration with Operation, Quality and Regulatory, and requires collaboration with program management to provide sufficient details into the Integrated Project Plan (IPP).
The position reports to the Vice President, Technical Operations Strategy, with a dotted line to Program Management (PMO).
- In support of the CMC strategy, translate the strategy into project plans with defined deliverables and deadlines, and drive the cross-functional teams and manage inter-dependencies across Technical...
Browse similar: Startup jobs · Remote jobs