Product Development Manager

Description:

Reporting directly to the Vice President, Drug Development, you will project manage all CMC activities associated with their drug development program. You will plan, coordinate and support all aspects of drug substance and drug product supply. Bringing strong communication skills, you will manage their ongoing collaborations with CDMOs to ensure success.

• Facilitate planning of CMC activities across drug substance, drug product and clinical supply chain to align dependencies, schedules, and delivery commitments, including the provision of logistics and supply chain management support.
• Support CDMO activities associated with clinical supply, including technical transfer, vendor assurance, and documentation, review and tracking of manufacturing and stability programs.
• Support writing, review, publication, and filing of CMC-related regulatory documents including those associated with INDs and product registration submissions.

The Requirements

• Tertiary-level qualification in chemistry, pharmacy, molecular biology, or related field.
• At least 5 years of experience in product development managing CMC activities, projects, and budgets in a cGLP/cGMP environment.
• Strong understanding of the drug development process within a regulatory environment, ideally relating to small molecule drug candidates.