Director Process Development CMC

Director Process Development CMCI 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 lifecycleLeading and empowering the Process Development Team for process development, formulation development, process scale-up, optimization, and technical transferProvide 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 clinicalcommercial 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 andor 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 experienceExperience in Cell therapy development and some experience in iPSC derived Cell TherapyExperience in cell line development, cell banking, and characterization.Direct experience working with CDMOs and supporting tech transfer andor GMP clinical manufacturing operations.Experience in CMC authoring for IND sectionsStrong understanding and technical knowledge of GMP processes, process design for drug substance and drug product, scale-up, control strategyTeam leading experience highly preferredApply today or reach out directly to

Created: 2024-10-22