- Act as the subject matter expert, advising collaborators on the optimal approach for their clinical and research projects.
- Lead troubleshooting and Root Cause Analysis activities; provide analysis of results and articulation of findings to clients through written reports and face to face meetings.
- Thoroughly understand and streamline laboratory processes to enhance scientific accuracy and robustness, especially in high-throughput environments.
- Implement strategies to minimise errors and ensure precision in process design.
- Address scientific issues and provide troubleshooting support for processes and projects.
- Define quality assurance methods, frequency, and acceptance criteria for processes.
- Develop plans and guide validation scientists and application scientists in conducting regular validations and pilot studies for new processes.
- Review and approval of reports on validations and pilot studies.
- Collaborate with the Quality team to ensure processes and documentation meet required standards.
- Chair monthly Data Analysis Data Quality, DADQ meetings for comprehensive data analysis and quality checks.
- Ensure scientific processes meet required quality standards, including UKAS 15189 and GCP standards.
- Plan and oversee the AQE activities which supports ISO15189 accreditation.
- Work with the Lab Ops team to identify gaps and continuously improve processes.
- Collaborate with Lab Development and Lab Ops to optimise the end-to-end process, reducing costs, wastage, and enhancing quality.
- Maintain an awareness of new / emerging technologies and tools.
- With the Head of Laboratory Development advise the Senior Leadership Team of any scientific and technological opportunities.
- Develop scientific training materials for lab technicians and conduct regular workshops on the scientific principles behind our processes.
- Understand sample storage projects, identify challenges, and propose effective solutions.
- Understand sample traceability procedures currently implemented and work on continuous improvements.
- Improve and maintain standards of operations to align with GCP, UKAS, and other relevant standards.
- Improve the Process and Data integrity within the business.
- Oversee processes and documentation to ensure suitability for HTA standards and maintain compliance.
- A degree in a biomedical discipline with a PhD or equivalent experience in a relevant area.
- Highly collaborative individual who can coach peers and communicate effectively across departments.
- Demonstrable knowledge of DNA/ RNA extraction, quantification and normalisation methodologies.
- Experience of working with LIMS platforms.
- Knowledge and experience of working within an HTA-licenced environment.
- A background in working to ISO quality accreditation standards (e.g. ISO15189, ISO:17025, ISO:
- Demonstrate the ability to influence senior managers and decision makers at all levels, in all organisations.
- A motivated self-starter who takes a pro-active approach to all aspects of their work including implementation of new technologies and methodologies, development of quality or productivity improvement programmes and with an aptitude for problem-solving.
- Market-competitive salary.
- The opportunity to be part of a respected Not For Profit organisation in the Life Sciences industry.
- A supportive and collaborative work environment.
- The satisfaction of contributing to meaningful scientific advancements.
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Principal Scientist - Milton Keynes, Buckinghamshire, United Kingdom - Michael Page (UK)
Description
About Our Client
Our client is a market-leading provider of high throughput end-to-end sample processing solutions, and is looking for a Principle Scientist to join the team, where you will be directly reporting into the Director of Quality & Compliance.
Job Description
The successful applicant will be involved in the preparation of SOPs, risk assessments and training schedules.
As a Principal Scientist, you will work closely with the Head of Laboratory Development and Business Development Team to develop new business processes to meet the needs of the changing markets. You will in conjunction with the Head of laboratory Development horizon-scan new technologies in the marketplace and, following cost-benefit assessments, make suitable and realistic recommendations to the Senior Leadership Team for the investment in new capabilities which will enhance the company's presence on the scientific stage. Key Responsibilities: Subject Matter Expert:The Successful Applicant
What's on Offer
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