Associate Director, MSAT Product Leadership

Associate Director - MSAT Product Leadership

Are you a strategic thinker with a passion for driving innovation in biopharmaceutical manufacturing? This industry leading global biopharma is seeking a dynamic Associate Director to lead a team of product stewards responsible for the lifecycle management and technical oversight of commercial biologics.

In this pivotal role, you will guide cross-functional initiatives, shape global regulatory strategies, and ensure robust control frameworks for high-impact therapeutic products. This is a unique opportunity to influence global CMC submissions and continuous improvement efforts in a highly collaborative environment.

Key Responsibilities:

• Lead and mentor a team of product leaders, fostering technical excellence and strategic thinking.
• Oversee the development and refinement of control strategies across the product lifecycle.
• Drive the preparation and execution of global CMC submissions and regulatory responses.
• Provide strategic input into process validation, annual product reviews, and continued process verification.
• Collaborate with global regulatory, quality, and technical teams to ensure alignment and compliance.
• Identify and implement opportunities for process optimization and innovation.
• Represent the product team in cross-functional governance and regulatory interactions.

Ideal Candidate Profile:

• Advanced degree in a scientific discipline (Ph.D. preferred) with 15+ years of experience in biopharmaceutical development, MSAT, or CMC roles.
• Proven expertise in regulatory strategy and technical writing for global submissions (FDA, EMA, PMDA, NMPA, etc.).
• Deep understanding of ICH guidelines, validation practices, commercial-scale biologics manufacturing, & lifecycle management.
• Strong leadership presence with the ability to influence across functions and drive decision-making.
• Demonstrated success in managing complex projects and navigating matrixed organizations.
• Passion for innovation, continuous improvement, and challenging the status quo.