Validation and Study Coordinator Lead Scientist
4 days ago
Company Description
**Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.**
**In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 58,000 staff across a network of more than 1000 independent companies in over 54 countries and operating more than 900 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.**
**In 2021, Eurofins generated total revenues of EUR € 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years.**
**Job Description**:
**You would be working Monday to Friday conducting hours flexibly within 07:00 to 19:00 working a 37.5 hour week.**
The purpose of this job is associated with the performance of method validation/development activities (study director-type activities) within the Method Validation Group within the client’s Analytical Service Department.
Job Responsibilities:
- To lead multiple projects simultaneously and ensure wet work, protocol and report compilation planned and scheduled appropriately and communicate progress to all stakeholders.
- To plan and complete assigned tasks within the required time frame.
- To collate, analyse and interpret scientific data, sign off routine assays and prepare data tables.
- To lead standard trouble shooting/out of specification investigations as required.
- To support and mentor a small team of colleagues.
- Preparation of scientific document with increasing level of complexity e.g. test methods, reports or protocol.
- To perform experimental work for a range of analytical methods with an increasing level of complexity without supervision.
- To perform laboratory/method housekeeping, perform routine instrument maintenance and reagent/consumable stock checks.
- Deliver departmental training and promote good scientific practice by coaching and/or mentoring junior scientists/technologists.
- Participate in evaluating and driving new innovations to the Method validation department.
- Understand & comply with company policies and departmental practices, regulatory and statutory requirements.
- Review assays for validation, method transfer and qualification studies against standard operating procedures, protocols and GMP.
- Utilize a broad range of specialised analytical equipment including HPLC based testing, electrophoresis, Impurity ELISA and qPCR.
- Critically assess all results and report any observations or concerns to QC management in a timely manner.
- Identify, assess and implement process improvement projects.
- Train staff to reinforce best practice. Generate and improve training packages.
- Support customer and regulatory audits as required.
- Work to high level of GMP.
- Identify any opportunities for improvement of quality and service and Implement continuous improvement.
- The scope of work shall be conducted to a high level of proficiency within the required time frames and associated data collated and reported in line with the preferred format.
- Raise and complete regulatory records as required and prepare GMP documentation.
- Conduct laboratory housekeeping and performing instrument maintenance and reagent / consumable stock checks.
- Assist in the preparation and review and revision of area documentation e.g. SOP's, Reports, Protocols.
- Highly proficient in the training of other personnel and providing mentorship.
- To document data as dictated by current client policies and procedures.
- To ensure that all documentation is carried out on time, is accurate and legible and conforms to the relevant quality standards.
- Attend regular client/Eurofins team meetings. Engage in these meetings, gaining learning and understanding of the wider communities.
- Ensure that the customer gets the best possible service by ensuring 100% ethical work standards.
**Qualifications**:
- Four to six years’ relevant experience in a chemistry/method validation discipline.
- Experience in people manag
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