Associate Director - Formulation Sciences

4 days ago

Apply Now

Receive Emails with Similar Jobs

Nuvalent, Inc.

WebsiteLinkedInAll Job Openings

11 - 50

Description

• Reporting to the Senior Director, Formulation Sciences, the Associate Director, Formulation Sciences will act as late-stage drug product subject matter expert and will immediately be responsible for guiding drug product process validation toward commercialization. • The successful candidate must demonstrate a proven record of working in a virtual environment with CDMOs to deliver commercial supplies in support of fast-paced late-stage development programs. • Using critical and strategic thinking, the Associate Director, must be able to develop and execute the process validation strategies for successful product commercialization. • This individual has responsibility for support of drug product process validation, scale up, and post-approval changes (SUPAC) and routine commercial manufacturing activities across Nuvalent’s contract research and manufacturing organizations. • The primary accountability is being the steward for the product development and manufacturing as these programs transition through development and into commercialization. • The ultimate goal will be to ensure robust process and manufacture strategies for consistent commercial supply.

Requirements

• PhD in pharmaceutical sciences, or chemical engineering with a minimum of 8 years or MS/BS with 15+ years of industry experience. • Proven track record on drug product process validation, scale up and post-approval changes and commercial manufacture. • Must have experience on solid dosage form (tablet) late-stage process validation through commercialization. • A strong understanding and knowledge of CGMP/ICH regulations and an ability to apply them to drug product development and manufacturing is required. • Effectively manage late-stage validation, post-approval changes and commercial manufacture activities within a virtual working environment. • Experience with implementation of QbD strategies and DoE approach during drug product Life-cycle management. • Manage the outsourcing manufacturing activities at CDMO sites to meet CMC goals. • Mastery of current ICH guidelines and related industry guidelines and practices. • Ability to author and review relevant development reports as well as regulatory dossiers. • Up to 25% travel is expected, both domestically and internationally.