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Senior Director, CMC Development Lead

3 months ago

Reston, Virginia, United States Fraser Dove International Full time
Sr. Director - CMC Development Opportunity

Fraser Dove International is partnering with a leading healthcare organisation to find an innovative leader to oversee CMC Development and lead the manufacturing operations of radiopharmaceutical products.

Your Key Responsibilities:
  • Lead multidisciplinary teams to develop, manufacture, and supply novel PET radiopharmaceuticals.
  • Ensure compliance with global GMP guidance and regulatory requirements.
  • Drive continuous improvement initiatives to optimize processes and improve efficiency.
What You Will Do:

As the Sr. Director - CMC Development, your duties and responsibilities will include:

  • Lead cross-functional teams to develop, manufacture, and supply novel PET radiopharmaceuticals.
  • Collaborate with team leaders to ensure seamless execution of CMC strategies.
  • Direct the operation of just-in-time manufacturing of PET radiopharmaceutical IMP at CMOs globally.
  • Develop and execute supply chain strategies for materials needed in PET radiopharmaceutical manufacturing.
  • Ensure compliance with global GMP guidance and regulatory requirements from agencies like FDA, EMA, and PMDA.
  • Partner with global vendors to ensure timely and quality delivery of CMC activities.
  • Drive continuous improvement initiatives to optimize processes, reduce costs, and enhance efficiency.
  • Manage CMC documentation lifecycle and transition late-phase products to commercial operations.
  • Mentor and develop team members to foster their professional growth.
  • Monitor project progress, budget, and resource allocation.
Requirements:
  • Advanced degree in a relevant scientific or engineering field.
  • Experience with PET drug development.
  • Proven leadership skills in managing multidisciplinary teams in drug development and supply.
  • Advanced understanding of cGMPs and CMC regulatory requirements.
  • Ability to manage people and drive engagement.
  • Exceptional problem-solving and decision-making skills.
  • Excellent written and verbal communication skills.
  • Superior organisational skills and adaptability in a fast-paced environment.