Method Development

Overview Method Development & Validation Specialist – join Eurofins PSS Insourcing Solutions. This role is based at the Currabinny site. Eurofins PSS is a global leader in scientific insourcing services, with over 15 years of experience in Ireland and more than 22 years globally.
We have exciting opportunities to join our innovative and multi award-winning Professional Scientific Services (PSS) teams. The role supports the delivery of high-quality analytical development, method validation and transfer in accordance with regulatory guidelines, within a Professional Scientific Services (PSS) team to meet client requirements and timelines.
Job Description The primary purpose of this role will be to develop and optimise analytical methods along with method validation and transfer according to regulatory guidelines. The role will involve participating in a Professional Scientific Services (PSS) team to ensure the highest quality and productivity standards are met along with the agreed client requirements and timelines.
Responsibilities Complete analytical data collection, interpretation and characterization of compounds while ensuring proper documentation of experimental data is adhered to.
Support innovative development of new analytical methods as well as improvement and optimization of current methods.
Provide technical expertise and analytical support for the introduction of new products to the Cork site, including method development, validation/qualification and transfer of methods to clients as required.
Lead in troubleshooting analytical technical challenges during the development, validation/qualification and transfer of methods.
Communicate regularly with client, providing updates on project progress, addressing technical queries and delivering client project requirements to defined timelines.
Ensure the delivery of projects within the required timeframe and ensure that the site’s technical, quality and safety metrics are achieved.
Provide suitable training where required to adopt new practices.
Review and approve standard operating procedures (SOPs), laboratory methods, COSHH assessments, laboratory investigational reports, validation protocols, risk assessments, reports & protocols.
Adopt ALCOA+ principles and ensure team working in accordance with registered methods and current Good Manufacturing Practice.
Take a lead role in the approval process, verifying the quality and accuracy of analytical results and determining if material meets predefined acceptance criteria per SOPs and specifications.
Act as an analytical expert, providing expertise in GMP and laboratory practices; lead investigations or project/equipment design as required.
Identify out-of-specification results, design root cause experiments and retest plans, and ensure investigations are completed in a timely manner with sound scientific rationale.
Work on long-term objectives to deliver improvements or embed changes within the laboratory; own projects from concept to delivery with progress updates throughout the lifetime of the project.
Communicate regulatory issues with senior team members and ensure the scientific conduct of projects.
Qualifications An honours degree in Chemistry or a related discipline is required.
At least 5 years’ experience in an analytical laboratory.
Some leadership skills would be advantageous.
Extensive knowledge of method development and method validation.
Experience analyzing APIs, raw materials and excipients with analytical 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 using common laboratory instruments and software for the above techniques.
Experience in problem solving and troubleshooting analytical equipment and methodologies.
Competence in the use of corporate IT systems and Microsoft packages.
Strong understanding of laboratory procedures and data integrity; awareness of national/international pharmaceutical regulatory requirements.
Familiarity with equipment/method validation and transfer procedures.
Seniority level Associate
Employment type Full-time
Job function Science
Industries Biotechnology Research and Pharmaceutical Manufacturing
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