OverviewThe Waters Advanced Diagnostics (ADx) Division provides globally recognized scientific and commercial leadership in clinical diagnostics, enabling laboratories to deliver high-quality, reliable results that improve patient care. Through workflow-based solutions, the ADx division advances the adoption of LC-MS as a routine diagnostic technology across global clinical markets.
The Technical Operations Manager is a new role created within the ADx LC-MS R&D organisation responsible for end-to-end process verification and validation, scale-up, and transfer of manufacturing processes to support robust, compliant, and cost-effective production for products to be distributed in highly regulated markets.
Responsibilities - Lead and manage the Technical Operations team.
- Responsible for design and execution of process verification and validation activities (IQ/OQ/PQ, PV, PPQ) aligned with regulatory expectations (FDA QSR, IVDR)
- Implement a quality by design (QBD) approach and mindset into the team.
- Ensure processes are capable, reproducible, and scalable.
- Manage transfer of products from R&D to manufacturing.
QualificationsEducation: Bachelor's or Master's degree in Engineering, Biotechnology, Life Sciences, or related field.
Experience: 8+ years experience in manufacturing, process development, or technical operations
Competencies: Strong experience in: - Process validation (IQ/OQ/PQ, PPQ) & Scale-up and technology transfer in regulated environments (IVD, medical devices, pharma, biotech).
- Statistical analysis and process capability tools.
- Proven track record of delivering robust, scalable manufacturing processes.
Travel (If Applicable): Minimal
Company DescriptionWaters Corporation (NYSE:WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, our innovative portfolio harnesses deep scientific expertise across chemistry, physics, and biology. We collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance. Through a shared culture of relentless innovation, our passionate team of ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide.
Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters complies with all applicable federal, state, and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business needs at the time.
