CMC Director
Our client, clinical-stage biopharmaceutical company are 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:
1. Coordinate a technical team in the execution of a complex combination product development program working collaboratively within the cross functional team structure
2. Accountable for development of the drug substance synthesis process, drug product manufacturing, and the development of associated analytical methods
3. Develop and maintain the CMC Pharmaceutical development plan and budget, including all DS, DP and Analytical Development work packages
4. Implement the CMC strategy including vendor selection and management, clinical and commercial supply chain strategy, second source supply strategy and risk management
5. Manage CMC program risks and issues, evaluate contingency plans and risk mitigation activities, while ensuring effective communication with senior managementAuthor and review of Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, meeting requests, and briefing documents)
Requirements:
6. Minimum of Masters degree in relevant scientific discipline required, with 12+ years industry experience including R&D and / or Technical Development
7. Strong understanding of ISCH guidance’s across all relevant disciplines. An understanding of ISO 13485 and FDA regulations on drug-device combination product development is advantageous
8. Prior experience in working on combination product development programs essential
9. Experience in development of products for pulmonary delivery preferred
10. Proven ability to successfully achieve results within a multi-cultural and geographically diverse cross-functional team
11. An entrepreneurial, business-oriented mindset and willing to “roll their sleeves up” attitude
12. A self-starter and comfortable working on their own initiative
13. Ability to perform multiple tasks simultaneously under direction and prioritise workload
14. Maintain a professional and positive attitude and present clear instruction/direction to team members
15. Prov