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CMC Director

1 month ago

Dublin, Dublin City, Ireland TN Ireland Full time

CMC Director
Our client, a clinical-stage biopharmaceutical company, is currently recruiting for a CMC Director to join their team on a permanent basis. As CMC Director, you will coordinate, manage, and provide technical oversight of the CMC team responsible for the development of drug substance, drug product, and analytical methods.

Responsibilities:

  • Coordinate a technical team in the execution of a complex combination product development program working collaboratively within the cross-functional team structure.
  • Accountable for the development of the drug substance synthesis process, drug product manufacturing, and the development of associated analytical methods.
  • Develop and maintain the CMC Pharmaceutical development plan and budget, including all DS, DP, and Analytical Development work packages.
  • Implement the CMC strategy including vendor selection and management, clinical and commercial supply chain strategy, second source supply strategy, and risk management.
  • Manage CMC program risks and issues, evaluate contingency plans and risk mitigation activities, while ensuring effective communication with senior management. Author and review Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, meeting requests, and briefing documents).

Requirements:

  • Minimum of a Master's degree in a relevant scientific discipline required, with 12+ years of industry experience including R&D and/or Technical Development.
  • Strong understanding of ISCH guidance across all relevant disciplines. An understanding of ISO 13485 and FDA regulations on drug-device combination product development is advantageous.
  • Prior experience in working on combination product development programs is essential.
  • Experience in the development of products for pulmonary delivery preferred.
  • Proven ability to successfully achieve results within a multicultural and geographically diverse cross-functional team.
  • An entrepreneurial, business-oriented mindset and a willingness to "roll their sleeves up."
  • A self-starter and comfortable working on their own initiative.
  • Ability to perform multiple tasks simultaneously under direction and prioritize workload.
  • Maintain a professional and positive attitude and present clear instruction/direction to team members.
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