CMC Program Coordinator

1 week ago


Maryland, United States Meet Full time

Company Overview: Meet is an innovative biotechnology start-up dedicated to advancing immunotherapy solutions. The organization aims to enhance the immune system's functionality to combat cancer and autoimmune disorders.

Position Overview: We are in search of a dynamic and resourceful CMC Project Manager to spearhead the management of Chemistry, Manufacturing, and Controls (CMC) initiatives for both small molecules and biologics, guiding projects from initial development stages to market launch.

Key Responsibilities:

  • Lead and manage CMC project operations for drug substance and drug product.
  • Engage with Clinical Development, Research and Development teams, and external advisors.
  • Prepare and maintain essential project documentation, including meeting notes, presentations, action items, and financial plans.
  • Oversee Third Party Manufacturers (CDMOs) deliverables and associated budgets.
  • Identify challenges and implement solutions, ensuring effective risk management.
  • Develop and refine CMC project plans and performance dashboards to meet project objectives.
  • Address complex challenges and eliminate obstacles to guarantee timely project outcomes.
  • Evaluate the implications of project modifications on schedules, budgets, and resources.
  • Clearly document and communicate strategic and operational decisions.

Qualifications:

  • A minimum of 5 years of experience in CMC project management within the pharmaceutical or biopharmaceutical sector.
  • A Bachelor's degree in a scientific, engineering, or health-related discipline is required.

Knowledge and Skills:

  • Exceptional project management, facilitation, and teamwork abilities.
  • Thorough understanding of the development and manufacturing processes for small molecules and biologics.
  • Familiarity with CMC regulatory requirements in Europe or the United States.


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