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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