Job Description

Position will be responsible for CMC leadership and project management for existing and new biologics projects from the drug substance perspective.

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 Asset Development Team.