Job Title: R&D Scientist for IVD Products
An exciting opportunity to contribute to the dynamic team responsible for the research and development of In Vitro Diagnostics (IVD) products. The team is involved in a diverse range of activities including analytical development, product development, verification and validation, and on-market support.
Responsibilities:
* Lead product development teams, supervise laboratory work for product development staff, train, and mentor new technical staff.
* Plan and perform design verification and analytical validation studies in the laboratory for IVD products.
* Develop, test, and refine prototype products.
* Generate test protocols, review, and analyze results, and generate V&V reports according to current applicable technical guidelines and quality management system requirements.
* Plan day-to-day activities, ensure sufficient supplies of materials to carry out tasks, and organize all proficiency testing within the laboratory.
* Carry out work in accordance with defined processes and laboratory procedures.
* Ensure that all work is compliant with existing quality processes.
* Perform investigative work as required by the organization to support reagent kits.
* Maintain detailed experimental records.
* Travel to other sites or countries for the transfer of knowledge.
In Return:
* Learning and development opportunities to further your career.
* Competitive salary ($93,000 - $110,000 per year).
* Private health insurance.
* Life and long-term disability insurance.
* Company pension contributions.
Qualifications:
* Proven experience working in a laboratory with analytical equipment such as HPLC or UPLC. Practical experience with LC/MS/MS would be an advantage.
* Ability to operate under a Quality System and knowledge of Good Laboratory Practice (GLP).
* Knowledge of the design control process and/or effective experience in a regulated environment (5 years+ ideally).
* Experience working in an R&D environment (pharmaceutical or medical device) would be advantageous.
* Familiarity with basic laboratory procedures, including gravimetric and volumetric preparations.
* Microsoft Excel training or substantial experience utilizing Excel is required.
Desired Experience:
* Product development and design experience. Experience working in an IVD R&D environment or a Clinical laboratory would be advantageous.
* Understanding of the requirements of quality management systems - ISO 13485 & 21 CFR 820.
* Knowledge of Non-Conformance, Change Control, and CAPA systems.
About Waters Corporation:
Waters Corporation (NYSE: WAT) is the world's leading specialty measurement company. We have pioneered chromatography, mass spectrometry, and thermal analysis innovations serving the life, materials, and food sciences for more than 60 years. 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.
We are a global organization with over 7,000 employees worldwide, operating directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries. At Waters, 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.
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.