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.
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.
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