Overview:
The Waters Clinical Business Unit (CBU) provides globally-recognized scientific leadership in the area of clinical and toxicology. We use that understanding to direct the development of innovative products and solutions to be workflow based, enabling our customers to solve critical analytical challenges and advance scientific understanding.
The Director of Assay Development is responsible for leading a dyanmic team, based in Wexford Ireland, for the design and development of diagnostic assay reagent kits and consumables. From feasibility to product launch including responsibility of all verification, validation and design transfer activities to support regulatory filings.

Responsibilities:

• Provide operational leadership to the liquid chromatography-mass spectrometry Assay Development team. Build organizational talent by creating a learning environment that ensures all employees have the training and skills needed to utilize available technology to meet business needs.
• Responsible for establishing the overall goals, objectives, governance, and time-lines for the Assay Development for all new development projects from feasibility phase to product launch.
• Responsible for delivering high-quality reagents and assays in compliance with applicable regulations and technical guidelines on time and on budget.
• Provide scientific guidance to assay development teams on the design and validation strategies for new products.
• Ensure close collaboration and alignment with Product Management and commercial organizations in the development and validation of customer requirements.
• Work closely with the Clinical Affairs, Regulatory Affairs and Quality departments for successful clinical studies, regulatory submissions, and design control processes.
• Oversee design transfer process from R&D to Manufacturing.
• Report progress to senior leadership as part of portfolio or project reviews.

Qualifications:

EDUCATION:

• Advanced degree (PhD, MSc) in a relevant scientific subject with a strong chemistry component or related field.

EXPERIENCE:

• Minimum 10 years industry work experience in a high volume/complexity ISO 9001, ISO13485 or GMP, Operational Excellence/Lean environment, with a proven track record of leading teams and managing complex projects.
• Strong leadership and project management skills, excellent communication abilities, and a deep understanding of regulatory requirements and assay verification and validation processes.
• Experience in developing FDA 510(k) and CE-IVD/IVDR registered products.
• Proficiency in LC-MS chemistries and instrumentation, and experience with analytical software and data analysis tools.

• Provide operational leadership to the liquid chromatography-mass spectrometry Assay Development team. Build organizational talent by creating a learning environment that ensures all employees have the training and skills needed to utilize available technology to meet business needs.
• Responsible for establishing the overall goals, objectives, governance, and time-lines for the Assay Development for all new development projects from feasibility phase to product launch.
• Responsible for delivering high-quality reagents and assays in compliance with applicable regulations and technical guidelines on time and on budget.
• Provide scientific guidance to assay development teams on the design and validation strategies for new products.
• Ensure close collaboration and alignment with Product Management and commercial organizations in the development and validation of customer requirements.
• Work closely with the Clinical Affairs, Regulatory Affairs and Quality departments for successful clinical studies, regulatory submissions, and design control processes.
• Oversee design transfer process from R&D to Manufacturing.
• Report progress to senior leadership as part of portfolio or project reviews