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, validation, transfer to operations and on-market support of Clinical IVD products.
Responsibilities
The Successful Candidate will:
- Lead technical feasibility aspects of new products and method for the clinical business to define and assess product requirements including development of prototypes, manufacturing processes, QC processes and stability evaluations.
- Transfer methods from assay research teams and assess for method robustness and validation.
- Design experiments and assessments for definition and development of the assay to assess against design goals.
- Plan and perform design verification and analytical validation studies in the laboratory for In Vitro Diagnostics products.
- Produce Product Specification and Requirements documentation and provide design direction to the development teams.
- Auther reports to meet regulatory requirments for IVDR and FDA bodies.
- Develop, and work in partnership with other stakeholders to implement, the project goals such that key attributes are risk managed and that project timelines are met.
- Contribute to design reviews, FMEAs, phase reviews and other project related activity as appropriate.
- Produce Product Verification documents to provide test evidence that design requirements have been met to meet regulatory industry guidance.
- Perform other duties in a professional manner as deemed necessary by the Organisation
- Complete Quality System related actions in a timely manner according to procedures e.g., CAPA, NCR
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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 regulated environment. (8 years+ ideally)
- 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.
- Experience working in an R&D environment (pharmaceutical or medical device) would be advantageous.
- Knowledge of Statistics for deign Control Analyze-It, minitab, R etc (desirable).
Competencies:
- Good written and verbal communication skills to ensure succinct report generation, succinct requirements writing and effective communication with teams and peer groups.
- Ability to work with process.
- Must be able to work independently and communicate with all levels of the organisation.
Travel (If Applicable):
- Travel internationally as required by the business for training, method transfer, attendance at Clinical study 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.