Purpose:

The Associate Director will be fully accountable for providing CMC leadership to both commercial and development projects with a focus on biologics drug substance. This role serves as a central leader within the Biologics Development and Launch (BDL) group.

Responsibilities:

• Develop comprehensive project plans, budgets, timelines and strategy; biologics projects at all stages of development are included, from phase I through commercial.
• Must present technical information regarding biologics manufacturing, process development and process characterization to management and to regulatory agencies.
• Prepare and review regulatory briefings and submissions to support clinical trials through registration of the product as well as post-approval life-cycle management.
• Manage multiple projects at various stages of development.
• Represent assigned projects on the multidisciplinary Product Presentation and Device Strategy Team (PPDST) and collaborate with stakeholders including R&D, RA, and Operations (MES, QA, sites, Supply Chain, purchasing, etc.).
• Participate in or lead/coordinate Governance efforts such as Product Performance Teams or gate reviews.