Associate Director, Program Management CMC Biologics - Remote

Overview

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.

In Short

• Develop comprehensive project plans, budgets, timelines, and strategy for biologics projects.
• Present technical information regarding biologics manufacturing and process development.
• Prepare and review regulatory briefings and submissions.
• Manage multiple projects at various stages of development.
• Represent projects on multidisciplinary teams and collaborate with stakeholders.
• Participate in or lead governance efforts such as Product Performance Teams.

Requirements

• Ph.D. in biochemistry, biochemical engineering, cell biology, or related field.
• 8+ years of industrial experience.
• Strong writing, presentation, and communication skills.
• Technical understanding of biologics manufacturing and quality issues.
• Ability to influence and collaborate in a matrixed team environment.
• Experience in biologics manufacturing process support or development.

Benefits

• Comprehensive benefits package including paid time off.
• Medical/dental/vision insurance.
• 401(k) participation.
• Eligibility for short-term and long-term incentive programs.