Director Process Development CMC
I am currently partnered with an exciting innovative Cell Therapy Biotech developing derived immune cell therapy products addressing significant opportunities with unmet clinical needs. I am collaborating with the CTO who is expanding the CMC team and currently seeking a Senior Director of Process Development.
You will be responsible for leading and growing a high performing team and responsible for the process development and external manufacturing to support their Cell Therapy Pipeline (iPSC)
Main responsiblities:
- You will define and execute process development and tech transfer activities to enable iPSC expansion and differentiation in GMP manufacturing throughout the product lifecycle
- Leading and empowering 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 effort.
- 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.
Main Qualifications and experiences:
- Degree in a relevant field and over 10 years 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
Apply today or reach out directly to rbanton@barringtonjames.com
