Principal Specialist, Data Review – Analytical Method Development

Google Chrome Microsoft Edge Apple Safari Mozilla Firefox Principal Specialist, Data Review – Analytical Method DevelopmentFull-timeCompany DescriptionEurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical 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, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA.Group's key figures are approx. 6.95 billion Euros turnover, over 950 laboratories across 60 countries and about 63,000 staff.Job DescriptionKey ResponsibilitiesIndependently review analytical method development data, protocols, reports, and supporting documentation to ensure accuracy, completeness, and scientific soundness.Evaluate chromatographic method development strategies, experimental design, and data interpretation for alignment with client expectations and regulatory requirements.Verify analytical data, including chromatographic outputs (e.g., HPLC, GC, IC, GCMS, LCMS), calculations, system suitability, and method performance characteristics.Ensure all work complies with GMP, data integrity principles (ALCOA+), internal SOPs, and applicable regulatory guidelines (e.g. ICH).Identify discrepancies, errors, or gaps in data and documentation, and drive resolution with appropriate stakeholders.Partner with Analytical Scientists and Project Group Leaders to ensure accurate interpretation and reporting of method development work.Provide client support as needed by offering technical insight and clarification related to data review findings.Serve as a technical resource for junior reviewers and scientific staff, providing guidance on data review practices and regulatory expectations.Contribute to the development and refinement of review procedures, best practices, and training materials.QualificationsQualifications Required: Master’s degree in a scientific discipline (Chemistry or related field).Minimum of 10 years of industry experience, including at least 5 years in analytical method development.Strong scientific understanding of analytical techniques and instrumentation (e.g., HPLC, GC, IC, dissolution, mass spectrometry).Strong understanding of chromatographic method principles, including impurity analysis, peak purity evaluation, forced degradation, method specificity, selectivity, resolution, robustness, accuracy, precision, linearity, and sensitivity.Proven ability to interpret complex scientific data, review protocols, and analytical reports.Exceptional attention to detail and commitment to data accuracy and integrity.Strong communication skills with the ability to collaborate effectively and provide clear, constructive feedback.Experience with data integrity expectations and regulated laboratory environments.Familiarity with electronic systems such as LIMS, ELN, Empower, Mass Hunter. Additional InformationKey Candidate Attributes:Self-motivation; excellent quality of work and attention to detailAbility to communicate effectively with coworkers and internal/external clientsAbility to learn new tasks quickly and to move easily from task to taskAbility to handle prioritization and multiple tasks simultaneouslyAbility to use a personal computer and learn necessary programsGood communication skills (oral and written)Organizational ability and good judgementScience background/education and/or laboratory experienceStrong Math SkillsLogical Thinking, Good Reasoning AbilityMotivation to excelCoaching/mentoring of peersBy clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party...