POST Recruitment are recruiting for a Research and Development Specialist to join a medical innovation company based in York.
The Research and Development Specialist is responsible for the execution of analytical technical activities and ensuring their quality. Including development of procedures for test development, method validation and implementation. Working with the Research and Development Manager to provide scientific support to clinical trials clients as well as the scientific affairs, proposals and business development teams.
- Provide supporting information to Scientific Affairs in the evaluation of appropriate testing and/or methodology. Liaise with technical staff on feasibility of testing for new study requirements. Provide pricing as needed to proposals team.
- Selection of appropriate test methods; research / identify suppliers of laboratory consumables and equipment options for new tests to support clinical trials opportunities.
- Under the direction of the Research and Development Manager facilitate assay development, conduct instrument validations and implement new testing to meets the needs of all clients, including FDA and non-FDA approved assays to support Clinical Trial clients.
- Develop validation plans, validation summary reports, stability study summary reports, correlation plans and correlation summary reports to meet regulatory requirements.
- Prepare standard operating procedures for newly developed test procedures and relevant documentation as necessary. Support the Research and Development Manager in the preparation of scientific data, including sample stability, method information, reference ranges to clients and/or Scientific Affairs as needed.
- Assist the Research and Development Manager with the documentation of QC ranges and with the documentation of quality assurance and compliance issues in laboratory related global Clinical Trials functional areas, including development and maintenance of Standard Operating Procedures. Assist in the investigation and corrective action for proficiency testing failures.
- Working with Scientific Affairs, facilitate the standardization of testing SOPs and instrumentation, and the harmonization of test reference ranges to facilitate the consistent execution of global studies.
- Assess the impact of manufacturer communications and complete associated documentation.
- Working with the Research and Development Manager to provide supportive information for consultation and technical support to clinical trial clients and laboratory staff. Participate on teleconference calls with clients and formulate written responses to clients as needed.
- Perform laboratory testing using various laboratory techniques as necessary. Provide support to the laboratory one day per week.
BSc or higher qualification, PhD would be an advantage in a relevant scientific subject, minimum of 3 years clinical laboratory experience required.
If you are interested in this role, please apply ASAP. This vacancy is being advertised by Post Recruitment Ltd.
The services advertised by Post Recruitment Ltd are those of an Employment Agency, visit our website for more details