Assay Development Director

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.

Competencies:

• Product / Process technologies skills.
• QMS training to ISO9001, ISO13485 and 21CFR Part 820 regulatory standards.
• Ability to work on own initiative and as part of a multi-disciplinary team.
• Be self-motivated and have excellent problem solving and analytical capabilities coupled with effective planning and execution rigor.
• Strong project management skills.
• ‘Change Agent’ focused on continuous improvement of the business.
• Open-minded, positive and enjoys working in a high energy and fast paced environment.

Travel (If Applicable):

• Travel will be expected as part of this role (up to 20%), visiting customer sites, conferences etc.

Company Description

Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials, and food sciences for over 60 years. With approximately 8,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries. Our team focuses on creating business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.   

Working at Waters enables our employees to unlock the potential of their careers. Our global team is driven by purpose. We strive to be better, learn and improve every day in everything we do. We’re the problem solvers and innovators that aren’t afraid to take risks to transform the world of human health and well-being. We’re all in it together delivering benefit as one to provide the insights needed today in order to solve the challenges of tomorrow. 

Diversity and inclusion are fundamental to our core values at Waters Corporation. It is our responsibility to actively implement programs and practices to drive inclusive behavior and increase diversity across the organization. We are united by diversity and thrive on it for the benefit of our employees, our products, our customers and our community. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or protected Veteran status.