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
Please give concise bullet points on job responsibility.
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.
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