Hiring Organization / Company: Waters Corporation
Basic Salary: To Be Discussed
Employement Type: Full-Time
With the growth in precision medicine, it is an exciting time for LC-MS in clinical diagnostics. For 10+ years, PCR-NGS techniques have been widely used for clinical diagnostics. Clinicians now want a real-time understanding of disease states, requiring a more complete picture of proteins, lipids, and steroids. LC-MS based assays are critical to provide this level of insight with their analytical specificity, sensitivity, and capacity to analyze simultaneously multiple analytes.
Reporting to the Global Agile Team Leader, the Principal Product Development Chemist will join a passionate, agile team to develop innovative solutions to address high unmet needs and establish Waters as the leader in clinical LC-MS diagnostics markets. This position is based at Wexford, Ireland.
- Participate in product technical feasibility aspects of projects to define and assess product requirements including development of prototypes, manufacturing processes, QC processes and stability evaluations.
- Support and conduct product verification and validation activities for In Vitro Diagnostic & Research Use Reagent Kits in a regulatory-compliant manner.
- Product release testing- Value Assignment (QC) of materials in an efficient and compliant manner
- Provides on-market support to the Clinical Diagnostics Group as required- responsible for supporting products on market with respect to investigations and process changes.
- Act as designee for supervisor/manager for laboratory investigations, QC release and stability testing as required.
- To train and supervise more junior members of project teams and provide feedback on performance to supervisor
- Perform and plan design verification and analytical validation studies in the laboratory for In Vitro Diagnostics products.
- Generate test protocols, review and analyze results, and generate V&V reports per current applicable technical guidelines and the quality management system requirements.
- To carry out quality control work in accordance with defined processes and laboratory procedures.
- To ensure that all work is compliant within the existing Health Sciences Diagnostics quality processes.
- Perform investigative work as required by the organization to support reagent kits
- Maintain detailed experimental records.
- Create and revise laboratory SOPs as required.
- To ensure health and safety standards are adhered to at all times.
- Bachelor's degree in a scientific subject is required, advanced degree in Chemistry preferred.
- Proven experience of working in a laboratory with analytical equipment such as HPLC or UPLC. Practical experience of 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 with demonstrable effective experience in a QC role and/or 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.
- IVD project development
- Product development and design experience
- Experience working in an R&D environment (pharmaceutical or medical device) or a Clinical laboratory would be advantageous.
- Understanding of the requirements of quality management systems - ISO13485 & 21CFR820
- Knowledge of None Conformance, Change Control and CAPA systems
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.
Job Location Information:
Location: Wexford, County Wexford
Date Posted: 2021-09-14
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