Executive Director, Cell Therapy CMC

We are seeking an exceptional and highly motivated CMC leader to join the BeiGene Cell Therapy team to enable the cell therapy development. Ideal candidate must be proficient in both CMC strategic planning, execution, and matrix team management. The successful applicant will spearhead the management of GTP/GMP facility, while develop internal cell therapy CMC capability including required resources, budgets, technology needs to enable programs.

Job Functions

• Strengthen internal cell therapy CMC capability by work with internal stakeholders and external partners to evaluate and enable cell therapy related GTP/GMP facility, along with delivering clinical material for cell therapy trials.

• Develop a vendor selection strategy to select services for development and manufacturing of discovery and oncology early development clinical assets.

• Plan, track, execute on programs from a pre-clinical stage through clinical proof of concept.

• Lead cross-functional team to author CMC/ quality sections of regulatory submissions (INDs/CTDs).

• Building scope and design of experiments as well as troubleshooting to generate robust GMP processes and analytics for cell therapy products.

• Assembling relevant CMC data and authoring regulatory filing documents (CMC sections) and responses to questions from regulatory agencies. Routinely supporting release of GMP batches of cell therapy products.

• Responsible for drug product management and generating and reviewing technical reports and technology transfer documents.

• Ensures effective communication and collaboration of all involved functions and third parties.

• Partnering and aligning with Discovery, Regulatory, Operations, Quality, and Clinical functions, and managing CMC-focused deliverables and timelines to move programs from lab to the clinic and beyond. Routinely presenting updates on CMC progress

Qualification

• Doctoral degree in biochemical engineering, bioengineering, biotechnology, or relevant process development and manufacturing of biologics.

• =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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.