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CMC Program Coordinator

2 months ago

Maryland, United States Meet Full time

Company Overview: Meet is an innovative biotechnology start-up focused on advancing immunotherapy solutions. Our mission is to harness the power of the immune system to restore equilibrium and combat cancer and autoimmune disorders.

Position Overview: We are in search of a dynamic and forward-thinking 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 launch.

Key Responsibilities:

  • Lead and manage CMC project operations for drug substance and drug product.
  • Engage collaboratively with Clinical Development, Research and Development teams, and external advisors.
  • Develop and maintain comprehensive project documentation, including meeting summaries, presentations, action item trackers, and financial plans.
  • Oversee Third Party Manufacturers (CDMOs) to ensure deliverables and budget adherence.
  • Identify challenges and implement effective mitigation strategies as needed.
  • Formulate and update CMC project plans and dashboards to meet project objectives.
  • Address complex challenges and eliminate obstacles to ensure timely project outcomes.
  • Evaluate the implications 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 filing requirements in Europe or the United States.