of global regulatory CMC strategies for investigational and marketed cell and gene therapy products. This role is accountable...Job Description General Summary: The Director, Regulatory CMC leads a cross-functional team in the execution...
Job Description Technology Transfer Director, Technology Transfer Leader, Cell, Gene, and Biological Therapies... as possible. Vertex is seeking a talented individual to join our Process Development organization supporting our cell, gene and biologics...
: Must have experience with cell and gene therapy CMC development (CQAs, specifications, comparability) from late-stage development... used for cell and gene therapy products and knowledge of the cGMPs, USP/ICH, and regulatory guidance for commercial-stage...
GMP. Experience with the manufacturing processes of small molecule, cell therapy, gene therapy and other modalities... we remain on the forefront of science, medicine and technology. We are seeking a dynamic and experienced Director, External...
-modality medicine portfolio currently including small molecule, cell therapy and gene therapies, a global CMC scientific team..., cell therapy, gene therapy and other modalities. Co-Location Requirement This is a hybrid role based in Boston...
life cycle in Cell & Gene therapy and/or Biologics (ICH/EU/FDA/etc.). · In depth experience in all stages of clinical... justification of specifications, CMC clinical and commercial regulatory submissions. ·Work closely with the cross- functional...
/globally and across modalities (e.g., small molecule, cell/gene therapy, medical device) Broad and deep quality operations... across modalities (e.g., small molecule, cell, gene, device, biologics), GxP areas, and geographies. Drive continuous improvement...
, development or supply. Prior experience supporting CMC for cell and gene therapies and/or biologics. Capability to build cross... Operations at Vertex. Casgevy is a CRISPR-derived genetic therapy that treats the underlying cause of Sickle Cell Disease...
and Cell Therapy products. You are interested in… Developing and executing clinical supply chain strategies from study... therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera...