Associate Director Bioassay

Associate Director, Technical PDS&T

An 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.