Associate Director - Analytical Sciences

3 days ago

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Nuvalent, Inc.

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Description

• The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. • The Role: Reporting to the Head of Analytical Sciences within Technical Operations, the Associate Director, Analytical Sciences has responsibility for the strategic analytical aspects of drug substance and drug product development and manufacturing activities across the relevant Nuvalent CRO and CDMOs for late phase programs. • The Associate Director, Analytical Sciences will drive analytical strategy for late-stage small molecule oncology programs. • This role would entail internal and external facing responsibilities as a technical analytical sciences representative on cross-functional CMC teams. • The Associate Director will help to develop processes for managing products through Stage 3 validation (continued process verification) and post approval change management. • The successful candidate will participate in driving global regulatory CMC strategy for FDA and ex-US interactions and submissions. • The ability to thrive in a virtual environment in support of developing and delivering drug substance (DS) and drug product (DP) for fast-paced late phase clinical development and commercial programs will be critical. • The role will include leading the build-out of Nuvalent’s commercial analytical function focused on technical analytical support of commercial supply and lifecycle management. • Competencies Include: Excellent organization, communication, and multi-tasking skills; Exceptional interpersonal skills; A strong analytical mind; Ability to work productively, primarily from home; Proven track record solving analytical and QC challenges.

Requirements

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