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Head of Pharmaceutical Development

2 months ago


Philadelphia, Pennsylvania, United States Fraser Dove International Full time
Head of CMC Development Opportunity

Fraser Dove International is partnering with a pioneering life sciences organisation to find an experienced leader to oversee global CMC & MSAT activities.

About the Role

As the Head of CMC Development, you will be responsible for leading the development and manufacturing of novel pharmaceuticals for clinical trials, ensuring the seamless operation of contract manufacturing organisations (CMO) and supply chain activities, and overseeing the implementation of CMC regulatory and compliance strategies in alignment with global standards.

Key Responsibilities
  1. Lead cross-functional teams to develop, manufacture, and supply novel pharmaceuticals.
  2. Collaborate with CMC regulatory, manufacturing, and supply chain teams to execute CMC strategies.
  3. Oversee just-in-time manufacturing of pharmaceutical IMPs at global CMOs.
  4. Develop and execute supply chain strategies for manufacturing materials, precursors, and reference standards.
  5. Ensure compliance with global GMP and regulatory standards from FDA, EMA, and PMDA.
  6. Partner with global vendors to ensure timely and high-quality delivery of CMC activities.
  7. Drive continuous improvement in processes and cost efficiency.
  8. Manage CMC documentation lifecycle and ensure seamless transition of products to commercial operations.
  9. Stay updated on industry trends, regulatory changes, and technological advancements.
  10. Mentor and develop team members to enhance their contributions.
  11. Track project progress, budgets, and resources while reporting to senior management.
Requirements
  • Advanced degree in a scientific or engineering field.
  • Experience in pharmaceutical development is preferred.
  • Strong leadership and management abilities with cross-functional teams.
  • Expertise in cGMPs and CMC regulatory requirements.
  • Exceptional organisational and problem-solving skills.
  • Superior communication skills, both written and verbal.
  • Ability to work in a fast-paced, evolving environment.

Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. We take pride in helping exceptional life science organisations source the talent they need to design, manufacture, and distribute life-changing drugs, treatments, and devices which transform and save patient lives.