Overview
An exciting opportunity to become part of a dynamic team responsible for the R&D of IVD products. The team is responsible for a diverse range of activities including analytical development, product development, verification and validation and on-market support.
Responsibilities
- Lead product development team, 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 In Vitro Diagnostics products meeting the guidance documentation e.g CLSI.
- Troubleshoot atypical results and lead investigations to identify root cause.
- Develop, test and refine prototype products.
- Generate test protocols, review and analyze results, and generate V&V reports per current applicable technical guidelines and the quality management system requirements.
- Plan day to day activities, ensure sufficient supplies of materials to carry out tasks etc and organise all proficiency testing within the laboratory.
- Carry out work in accordance with defined processes and laboratory procedures.
- Ensure that all work is compliant within the existing quality processes.
- Perform investigative work as required by the organization to support reagent kits
- Maintain detailed experimental records.
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Qualifications
Education:
A degree in a scientific subject with a strong chemistry component and / or equivalent years' experience in industry.
Experience:
- 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.
- Knowledge of the design control process and/or with demonstrable effective experience in a development role (5 years+ ideally)
Competencies:
- Be highly goal-oriented and organized and be able to thrive in an atmosphere of shifting demands and priorities.
- Be able to work independently and as a member of a cross-functional team, to multi-task and prioritise to meet high expectations and tight deadlines.
- Must be results oriented and highly focused.
- Have technical writing and reviewing skills.
- Have excellent attention to detail. Traceable recordkeeping and ability to write and follow standard operating procedures / methods. Ability to work on one owns initiative and to adhere to GLP.
- Be self-driven and flexible who can allocate time and resources efficiently, effectively prioritize, and continually seek ways to improve individual and corporate efficiency.
- Excellent documentation and communications skills- Possess excellent oral and written communication skills as well as technical writing and reviewing skills.
Travel (If Applicable):
- Travel internationally as required by the business for training, method transfer and attendance at Clinical sites and conferences.
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.