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Senior CMC Project Coordinator

2 months ago

Maryland, United States Meet Full time

Company Overview: Meet is an innovative biotechnology start-up focused on advancing immunotherapy solutions. The organization is dedicated to reprogramming the immune system to restore equilibrium and tackle challenges related to cancer and autoimmune disorders.

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

Key Responsibilities:

  • Lead and manage CMC project activities for drug substance and drug product.
  • Engage with Clinical Development, Research and Development teams, and external partners.
  • Prepare and maintain essential project documentation such as meeting notes, presentations, action item lists, and financial plans.
  • Oversee Third Party Manufacturers (CDMOs) deliverables and associated budgets.
  • Identify potential challenges and implement effective mitigation strategies.
  • Develop and refine CMC project plans and performance dashboards to meet project objectives.
  • Address complex issues and eliminate obstacles to ensure timely project completion.
  • Evaluate the effects of project modifications on timelines, budgets, and resource allocation.
  • Clearly document and communicate both strategic and tactical 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 the US or Europe.