Morgan McKinley
Job title:
Associate Director Technical
Company
Morgan McKinley
Job description
Associate Director, Technical PDS&TAn exciting opportunity has come up for an Associate Director position in the area of product development, science and technology, located in Mayo. They will be working on a global scale team in both the areas of R&D and operations. We are looking for someone who has strong leadership experience, extensive experience with analytical methods and specifically Bioassays. This person will have worked in the areas of R&D and in operational roles throughout their career. The associate director will be overseeing multiple global late-phase projects in both the pipeline and commercial space.Responsibilities:
- Lead the PDS&T team which includes scientists ranging from scientist to principal level scientists in the areas of goal setting, performance management, people development, promotion recommendations and salary management through projects
- Guide cross-functional late-stage development and validation of analytical methods and global methods.
- Lead global initiatives and define CMC/analytical strategies for global product development programs.
- Troubleshoot analytical methods such as cell-based potent assays and biological assays.
- Oversee life-cycle management of test methods for commercial products.
- Liaise with early development functions in R&D, interacting with other functions in Operations, Regulatory as well as relevant technical plant functions.
- Lead method transfers to global regulatory agency laboratories.
- Responsibility/ownership for content of quality and global regulatory submission documents, responses to health agency requests and post approval filings. Including representing the company in discussions with regulatory bodies.
- Perform financial planning and execute budget responsibility.
Requirements:
- Master or PhD is essential
- Four plus years in a position of leadership
- A strong background and knowledge in Analytical Methods and Bioassays.
- R&D experience
- Minimum 8 years working in GMP environments.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR WHICH TOGETHER WITH OUR GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
Expected salary
Location
Ireland
Job date
Sat, 21 Dec 2024 23:57:18 GMT
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