Senior Director of Process Development
4 weeks ago
Director Process Development CMC
We are currently partnered with an innovative Cell Therapy Biotech developing derived immune cell therapy products addressing significant opportunities with unmet clinical needs.
As a key member of the CTO's team, you will be responsible for leading and growing a high-performing team and overseeing process development and external manufacturing to support the Cell Therapy Pipeline (iPSC).
Main Responsibilities:- Define and execute process development and tech transfer activities to enable iPSC expansion and differentiation in GMP manufacturing throughout the product lifecycle.
- Lead and empower the Process Development Team for process development, formulation development, process scale-up, optimization, and technical transfer.
- Provide strategic and technical CMC leadership for developing innovative, scalable expansion and differentiation processes to manufacture iPSC-derived cell therapy products.
- Support due diligence activities for selection of CDMOs and capacity planning for clinical/commercial manufacturing.
- Lead activities required to ensure successful transfer and execution of expansion and differentiation processes in GMP manufacturing, including technical oversight of external CDMOs.
- Collaborate closely with colleagues across different functions to best leverage internal and/or external capabilities to assist in process development efforts.
- Develop, review, and approve process development source documents, and author and review CMC sections for regulatory submissions. Support the Regulatory group in responding to agency questions.
- Degree in a relevant field and over 10 years of relevant experience.
- Experience in Cell therapy development and some experience in iPSC-derived Cell Therapy.
- Experience in cell line development, cell banking, and characterization.
- Direct experience working with CDMOs and supporting tech transfer and/or GMP clinical manufacturing operations.
- Experience in CMC authoring for IND sections.
- Strong understanding and technical knowledge of GMP processes, process design for drug substance and drug product, scale-up, control strategy.
- Team leading experience highly preferred.
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