CMC Director
3 weeks ago
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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