Associate Director / Director CMC Product Development (all genders) (fulltime, permanent)

As an Associate Director/Director CMC Product Development, you independently manage programs of various complexity utilizing a matrix approach. You lead Chemistry, Manufacturing and Controls (CMC) teams and Product Presentation and Device Strategy Teams (PPDST) of functional representatives from various departments and divisions for projects involving external collaboration partners per Pipeline Commercialization Model (PCM). In the role of PPDST co-chair for Asset Strategy Teams (ASTs) and key member of AST, you have accountability for creating a CMC strategy and development plan that aligns with the overarching asset strategy to effectively advance to the next key milestone and to deliver a differentiated product. You serve as the spokesperson for all CMC functions and ensures information flow among AST and various line functions and stakeholders. You will also partner with key collaborators, incl. Clinical, Regulatory, Operations, Quality, Preclinical Safety, ADME and Commercial organizations. Apprises CMC and Stakeholder Management of strategies, plans and risks through regular communications and periodic reviews throughout development and in support of global filings and

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