An exciting opportunity for an experienced Associate Director in the area of product development, science and technology, to join a leading pharmaceutical company located in Co. Mayo, Ireland. They will be working on a global scale in both the areas of R&D and operations. We are looking for someone who has strong leadership experience, extensive experience with analytical methods specifically Bioassays. This person will have worked in the areas of GMp, 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 project.
- 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:
- Subject Matter Expert in working with Bioassays
- Masters or PhD is essential
- At least four plus years in a position of leadership
- A strong background and knowledge in Analytical Methods and Bioassays.
- R&D experience beneficial
- Minimum 8 years' of experience working within GMP environments.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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