Morgan McKinley
Job title:
Associate Director (Bioassay Specialist)
Company
Morgan McKinley
Job description
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.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
Wed, 20 Nov 2024 05:10:47 GMT
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