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Director Process Development CMC

2 months ago

Boston, United States Barrington James Full time

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