Technical Operations Manager
About the role
Overview:
The 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.
Qualifications:
Education: 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 Description:
Waters 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.
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