Method Development

OverviewMethod Development & Validation Specialist – Full-time position at Eurofins PSS Site in Currabinny.Consider joining Eurofins PSS®, where people are the most important element in our business.Eurofins PSS® is a global leader of scientific insourcing services with over 15 years of service in Ireland and over 22 years globally.For more information about Eurofins PSS®, please visit our website and watch a message from our Global Head, Beth Di Paolo.We are a multi award-winning Professional Scientific Services (PSS) team delivering high-quality, compliant services in a cGMP environment.What can Eurofins offer you as an employee?Developmental opportunities and career progressionThe opportunity to work with a world-leading pharmaceutical and biotechnology companyAccessible locationPrivate Medical InsuranceIncome protection and life assuranceAnnual discretionary bonusFree parking onsiteFull use of the canteen facilities on the client siteAdditional annual leave days with continued serviceOpportunity to work on products helping to save lives across the worldThe primary purpose of this role is to develop and optimise analytical methods along with method validation and transfer according to regulatory guidelines.The role involves being part of a Professional Scientific Services (PSS) team to ensure the highest quality and productivity standards are met in line with client requirements and timelines.ResponsibilitiesComplete analytical data collection, interpretation and characterization of compounds with proper documentation of experimental data.Support innovative development of new analytical methods and improvement/optimisation of current methods.Provide technical expertise for the introduction of new products to the Cork site, including method development, validation/qualification and transfer of methods to clients as required.Lead troubleshooting of analytical technical challenges during development, validation/qualification and transfer of methods.Communicate regularly with client, providing updates on project progress and addressing technical queries to meet defined timelines.Ensure project delivery within the required timeframe and achievement of site technical, quality and safety metrics.Provide suitable training to adopt new practices where required.Review and approve SOPs, laboratory methods, COSHH assessments, laboratory investigational reports, validation protocols, risk assessments and related protocols/reports.Adopt ALCOA+ principles and ensure team compliance with registered methods and GMP.Lead approval processes, verify quality and accuracy of analytical results against acceptance criteria per SOPs and product specifications.Act as an analytical expert providing laboratory GMP knowledge; lead investigations or project/equipment design as needed.Identify out-of-specification results; design root cause investigations and retest plans with timely completion and sound scientific rationale.Work toward long-term objectives to deliver improvements and embed changes within the laboratory; own projects from concept to delivery with progress updates.Communicate regulatory issues and project status with senior team members.QualificationsAn honours degree in Chemistry or a related discipline is required.At least 5 years of experience in an analytical laboratory.Some leadership skills would be advantageous.Extensive knowledge of method development and method validation.Experience in analysis of APIs, raw materials and excipients with techniques such as chromatographic (HPLC, GC, IC), spectroscopic (IR, LC-MS, ICP-OES, Atomic Absorption), physical properties (particle size analysis) and/or pharmacopoeial testing.Proficiency in the use of common laboratory instruments and software for these analytical techniques.Experience in problem solving and troubleshooting analytical equipment and methodologies.Competent in the use of corporate IT systems; proficient with Microsoft packages.Strong understanding of laboratory procedures and data integrity, with emphasis on reporting accuracy.Familiar with equipment/method validation and method transfer procedures.Understanding of GMP environment and regulatory requirements.BenefitsWorking 39 hours per week on a day shift pattern.Benefits of pension contribution, medical insurance, health insurance and bonus included in package.Support from Eurofins Management and the client site team.Opportunity to work with fantastic people as part of a great team.Eurofins Scientificis an international life sciences company providing a wide range of analytical testing services, with a focus on safety, authenticity and quality across multiple industries.Eurofins aims to be a global leader in food, environmental, pharmaceutical and cosmetics testing and in genomics, discovery pharmacology, forensics, CDMO, advanced material sciences, and clinical studies support.Eurofins has grown from one laboratory in Nantes, France to a global network of laboratories and teams across many countries.Eurofins PSS Insourcing Solutions®is a global, award-winning insourcing solution that places our skilled team directly at the client site, delivering seamless operations while maintaining service, expertise and cGMP compliance.#J-*****-Ljbffr