Senior Vice President, CMC

2 weeks ago

Seattle, Washington, United States Mozart Therapeutics, Inc. Full time

Mozart Therapeutics, Inc. is a pioneering biopharmaceutical organization situated in Seattle, dedicated to the advancement of innovative immune engagers that specifically target a distinct subset of T lymphocytes. Our mission is to delay the onset and alleviate the symptoms of autoimmune diseases through the development of first-in-class immune modulators aimed at a novel regulatory T cell network.

The Senior Vice President, CMC is instrumental in guiding the trajectory of our pipeline by overseeing the manufacturing of drug candidate molecules throughout all development phases. This role entails providing strategic direction, technical expertise, and operational execution to ensure the successful progression of CMC development activities for Mozart's initiatives.

Key Responsibilities:

  • Oversee all CMC components of drug substance and drug product development, encompassing production cell line, upstream and downstream process development, formulation work, GMP manufacturing, analytical characterization, and clinical supply distribution.
  • Manage multiple priorities in a dynamic environment, employing swift problem-solving skills to guarantee timely supply of drugs for non-GLP toxicology studies, IND-enabling activities, and clinical trials.
  • Formulate strategies for drug substance and drug product development that align with clinical and commercial requirements, ensuring product quality and facilitating regulatory approvals.
  • Stay updated on Health Authority guidelines and contribute proactively to regulatory strategies.
  • Identify and oversee Contract Development and Manufacturing Organizations (CDMOs) for process optimization, GMP manufacturing, and supply of drug products.
  • Establish and maintain comprehensive project plans and SOPs, continuously evaluating risks and optimizing timelines.
  • Develop scalable, safe, and cost-effective manufacturing processes.
  • Communicate effectively with various functional areas and stakeholders to define and execute CMC strategies.
  • Collaborate with Quality Assurance and Regulatory teams to review and approve analytical documents and regulatory submissions.

Qualifications:

  • Proven experience in cGMP manufacturing and managing CRO/CDMOs for the production of regulatory materials.
  • In-depth knowledge of IND, IMPD, NDA, and EMA submissions.
  • Strong leadership skills with a focus on collaboration and teamwork.
  • Advanced degree in chemical or biological sciences; PhD or MBA preferred.
  • 15+ years of relevant CMC experience in the pharmaceutical industry.

Work Environment:

This position primarily operates in an office setting, requiring daily use of computers and other digital devices. The role may involve occasional work outside standard hours and may necessitate domestic and international travel.

Mozart Therapeutics, Inc. fosters an innovative and collaborative culture, seeking individuals eager to contribute significantly to the development of novel CD8 Treg modulators aimed at improving clinical outcomes for patients with autoimmune diseases. We offer competitive compensation and a comprehensive benefits package.

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