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.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 kitsMaintain detailed experimental records.Travel to other sites/ countries for the transfer of knowledge etc.In return you will receive:Learning and development opportunities to further your career.
Competitive salaryPrivate health insuranceLife and long term disability insuranceCompany pension contributions Qualifications 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 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.
Experience Desired: 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- ISO13485 & 21CFR820 Knowledge of Non Conformance, Change Control and CAPA systems