Our client is an exciting, rapid growing clinical stage biopharmaceutical business clearly focussed on establishing best in class teams across all its functions. Given the increase in activity within their global business our client is now seeking to fill a permanent position of CMC Director.
The Director, CMC, will coordinate, manage and provide technical oversight of the CMC team responsible for the development of drug substance, drug product and analytical methods. The role is key in the development program for a novel inhalation combination product, as well as intravenous and intranasal drug development programs.
Technical execution will involve managing internal technical experts, managing external vendors, and working closely with the Device Development team and Program Management to achieve the program objectives and timelines. A key requirement of the role will be the translation of the target product profile and commercial inputs into a coherent development and supply plan.
In this role the incumbent will be a key member of assigned program teams and will be responsible for delivering to program timelines and goals. Important interactions will be with the device development team, clinical supply team, centralized project management functions, Clinical Operations and Sciences, Quality and Regulatory Affairs. Experience of managing and achieving aims through a highly externalized model is essential, as is the flexibility for approximately 20% international travel. The role will report to the VP, Technical Development and Operational Planning.
- Coordinate a technical team in the execution of a complex combination product development program working collaboratively within the cross functional team structure.
- Accountable for 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 of Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, meeting requests, and briefing documents).
- Minimum of master’s degree in relevant scientific discipline required, with 12+ years industry experience including R&D and / or Technical Development.
- 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.
- Prior experience in working on combination product development programs essential.
- Experience in development of products for pulmonary delivery preferred.
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse cross-functional team.
- An entrepreneurial, business-oriented mindset a strong fit with the team and willing to “roll their sleeves up.
- A self-starter and comfortable working on their own initiative.
- Ability to perform multiple tasks simultaneously under direction and prioritise workload.
- Maintain a professional and positive attitude and present clear instruction/direction to team members.
- Proven ability to deliver results within multi-cultural and geographically diverse cross-functional team.
- Flexible, able to adjust, embrace and drive change.
- Resilient, energetic, and enthusiastic
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