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Director , CMC Product Development Lead
Location:
Abingdon
Description:
Adaptimmune is a clinical-stage biomedical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer. Primary Responsibility The CMC Product Development lead will be accountable for driving the product development and supply strategy for a specific Adaptimmune asset and have responsibility for developing a cross-functional CMC team supported by the relevant functions (Process & Analytical Development, MS&T, QC, QA, CMC Regulatory and Supply Chain). The individual will work with the representatives from those functions to define a CMC product development strategy integrated with the proposed clinical development plan, and to evolve the CMC development plan as clinical development progresses. The CMC Lead will be expected to provide matrix leadership to the team, to direct discussions, manage the creative tension on the project and between functions, and to own the arising decisions taken for the asset. Manage the creation of, and lifecycle, relevant CMC documentation, e. g. QTPP, CQA backssment, control strategy, etc. by the cross-functional team. Lead the cross functional team in development of suitable manufacturing process(es), analytical methods and the manufacturing / supply network strategy from FIH clinical studies through to commercial manufacture for the given asset. Define the product development strategy (manufacturing and analytical) integrated with an accelerated clinical development plan and prioritise work packages for the asset accordingly. Act as the CMC representative during interactions with. Visit ListedBuy for more information.
Company:
Adaptimmune
Posted:
January 2 on ListedBuy
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More About this Listing: Director , CMC Product Development Lead
Director , CMC Product Development Lead is a Executive Director Job at Adaptimmune located in United States. Find other listings like Director , CMC Product Development Lead by searching Oodle for Executive Director Jobs.
Director , CMC Product Development Lead is a Executive Director Job at Adaptimmune located in United States. Find other listings like Director , CMC Product Development Lead by searching Oodle for Executive Director Jobs.