Senior Vice President, CMC Operations

2 weeks ago

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

Mozart Therapeutics, Inc. is a pioneering biopharmaceutical organization based in Seattle, dedicated to the advancement of innovative immune modulators aimed at targeting specific T lymphocyte subsets to mitigate the effects of autoimmune disorders. We are on a mission to develop groundbreaking therapeutic agents that engage a unique regulatory T cell network.

The **Senior Vice President of CMC Operations** is instrumental in steering the future of our therapeutic pipeline by overseeing the manufacturing processes of drug candidate molecules throughout all developmental phases. This role entails providing strategic oversight, technical guidance, and operational execution to ensure the effective CMC development of Mozart's programs.

The successful candidate will manage both internal teams and external partnerships, collaborating closely with Contract Development and Manufacturing Organizations (CDMOs) and Contract Research Organizations (CROs) to facilitate the successful development and production of our advanced biologic therapeutic candidates.

Key Responsibilities
  • Oversee all CMC facets of drug substance and product development, including cell line production, upstream and downstream process development, formulation, GMP manufacturing, analytical characterization, and clinical supply distribution.
  • Effectively manage competing priorities in a dynamic environment, employing swift problem-solving skills to ensure timely drug supply for non-GLP toxicology studies and clinical trials.
  • Develop comprehensive strategies for drug substance and product development that align with clinical and commercial objectives, ensuring product quality and regulatory compliance.
  • Stay informed on Health Authority guidelines and contribute proactively to regulatory strategies.
  • Identify and supervise CDMOs for process optimization, GMP manufacturing, and supply chain management.
  • Establish and maintain detailed project plans, identifying risks and optimizing timelines while managing associated risks.
  • Design scalable, safe, and cost-effective manufacturing processes.
  • Accountable for managing multiple assets across various stages, from development to commercial launch.
  • Collaborate effectively with various functional areas to define and execute CMC strategies.
  • Identify and escalate key issues and resource needs as necessary.
  • Work closely with Quality Assurance and Regulatory teams to review and approve relevant documents throughout the CMC manufacturing process.
  • Prepare and review technical development reports and regulatory submissions, ensuring compliance with CMC requirements.
  • Act as the CMC expert in discussions with regulatory authorities and external partners.
Qualifications
  • Proven experience in cGMP manufacturing and managing CRO/CDMO relationships for regulatory materials and drug substances.
  • Demonstrated success in executing CMC activities from non-GLP material supply to GMP drug product manufacturing.
  • In-depth understanding of cGMP compliance and regulatory requirements across various jurisdictions.
  • Strong leadership skills with a focus on collaboration and teamwork.
  • Excellent communication skills, capable of engaging effectively with internal and external stakeholders.
  • Ability to travel as needed to fulfill role requirements.
Education and Experience
  • Advanced degree in chemical or biological sciences; PhD or MBA preferred.
  • 15+ years of relevant CMC experience in the pharmaceutical sector, with a minimum of 7 years in leadership roles.

Mozart Therapeutics fosters a collaborative and innovative work 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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