Senior Manager of Cell Therapy Development
7 days ago
We are seeking an exceptional and highly motivated leader to join our Cell Therapy team at BeiGene. As the Director of Cell Therapy Operations, you will play a critical role in enabling the development of our cell therapy programs.
Key Responsibilities- Strengthen our internal cell therapy capability by working with internal stakeholders and external partners to evaluate and enable cell therapy-related GTP/GMP facilities, as well as deliver clinical material for cell therapy trials.
- Develop a vendor selection strategy to select services for the development and manufacturing of discovery and oncology early development clinical assets.
- Plan, track, and execute programs from a pre-clinical stage through clinical proof of concept.
- Lead cross-functional teams to author CMC/quality sections of regulatory submissions (INDs/CTDs).
- Build scope and design of experiments, as well as troubleshoot to generate robust GMP processes and analytics for cell therapy products.
- Assemble relevant CMC data and author regulatory filing documents (CMC sections) and responses to questions from regulatory agencies. Routinely support the release of GMP batches of cell therapy products.
- Responsible for drug product management and generating and reviewing technical reports and technology transfer documents.
- Ensure effective communication and collaboration of all involved functions and third parties.
- Partner and align with Discovery, Regulatory, Operations, Quality, and Clinical functions, and manage CMC-focused deliverables and timelines to move programs from lab to the clinic and beyond. Routinely present updates on CMC progress.
- Doctoral degree in biochemical engineering, bioengineering, biotechnology, or relevant process development and manufacturing of biologics.
- At least 8 years of industrial experience in CMC of biologics. Experience with cell therapies is a plus.
- Broad understanding of all aspects of CMC, including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, distribution across multiple regions.
- Excellent writing skills. Good understanding of iPSC-related manufacturing processes and analytics is a plus.
- Experience authoring SOPs, regulatory and quality documents.
- Experience working in cGMP manufacturing facilities and IND filing of biological products.
BeiGene is a global biotechnology company that is dedicated to developing innovative therapies for cancer and other diseases.
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