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unique authority in executive search for global based innovation driven drug development companies
CMC Director
Led by a highly respected entrepreneurial leadership team, blessed with a proven track record in building successful young start-ups, our client is a young, exciting, rapid growing clinical stage biopharmaceutical business poised to deliver an important break though in a debilitating condition characterised by chronic unmet need.
This role offers an extraordinary opportunity for a high performer with a depth of expertise in the development of products for pulmonary delivery, ideally in bringing drug products through late-stage trials onto commercial approval.
This role is hybrid / can be based UK, Irl, EU locations.
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 for treatment of neurological conditions, as well as intravenous 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 pharmaceutical development plan.
Job Spec:
* Accountable for development of the drug substance, drug product, and associated analytical methods, via a risk-based approach, for a complex drug-device combination product. Develop and maintain the CMC pharmaceutical development plan and budget.
* Coordinate the CMC team in the execution of the development program, working collaboratively within the cross functional team structure.
* Define and implement the CMC strategy including vendor selection and management, clinical and commercial supply chain strategy, second source supply strategy and risk management.
* Manage the development of robust processes, developing the product and process control strategies that ensure the performance and safety of the drug.
* Manage CMC program risks and issues, evaluate contingency plans and risk mitigation activities, while ensuring effective communication with senior management.
* Provide scientific and technical leadership to the CMC team and CMOs throughout development and manufacturing.
* Author and review of Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, meeting requests, and briefing documents).
Person Spec:
* A passion to play a vital leadership role / make your mark in a young early start up.
* Minimum of master’s degree in relevant scientific discipline required, with 10+ years industry experience including R&D and / or Technical Development.
* Experience in development of products for pulmonary delivery strongly preferred.
* Understanding of ICH guidance’s across all relevant disciplines. An understanding of ISO 13485 and FDA regulations on drug-device combination product development and DPI product development is advantageous.
* Proven ability to successfully achieve results within a multi-cultural and geographically diverse cross-functional team.
* An entrepreneurial, business-oriented mindset and a strong fit with the Research team and willing to “roll their sleeves up”.
* A self-starter and comfortable working on their own initiative.
* Maintain a professional and positive attitude and present clear instruction/direction to team members.
* Resilient, energetic, and enthusiastic.
CV to gerry@rftgroup.ie
Seniority level
* Seniority level
Director
Employment type
* Employment type
Full-time
Job function
* Job function
Science and Research
* Industries
Pharmaceutical Manufacturing
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