Associate Director, MSAT Product Leadership


Maryland
Permanent
USD130000 - USD170000
Research And Development
PR/547190_1748467006
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 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) or Bachelors 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.

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