Senior Technical Expert (Research Scientist), Inhalation - Athlone, Ireland
at Thermo Fisher Scientific
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Work ScheduleStandard (Mon-Fri)Environmental ConditionsLaboratory SettingJob DescriptionResearch Scientist, InhalationJoin Us as a Research Scientist – Make an Impact at the Forefront of InnovationWe have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.Location/Division Specific Information Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. This role is based at our GMP analytical testing facility in Athlone, Co. Westmeath.The successful candidate will provide scientific leadership and technical support for client projects involving orally inhaled and nasal drug products (OINDPs), including dry powder inhalers (DPI), pressurized metered-dose inhalers (pMDI), nasal sprays, nebulized products, and related dosage forms.The role will involve leading the planning, execution, interpretation, and delivery of inhalation-focused studies, ensuring high-quality scientific output, regulatory compliance, and timely project completion. The candidate will contribute to inhalation product characterization and equivalence activities, including IVBE (in vitro bioequivalence), IVTE (In Vitro Therapeutic equivalence), aerodynamic particle size distribution (APSD) testing, and other inhalation-specific analytical and performance studies.The Research Scientist will act as technical project leader across multiple client projects, providing regular updates, reviewing and evaluating data, drafting reports and protocols, and participating in client technical discussions. The role requires strong hands-on experience with inhalation laboratory instrumentation and analytical techniques, including NGI (Next Generation Impactor), ACI (Andersen Cascade Impactor), Spraytec, SprayVIEW, and dissolution testing of orally inhaled and nasal drug products.In addition, the candidate will design and execute stability and inhalation procedures, support routine maintenance and troubleshooting of analytical instruments such as HPLC, UPLC, GC, ICP-MS, LC/MS, and GC/MS, and apply multiple detection techniques including UV, FL, CAD, ELSD, and IC. The role also includes supporting investigations, change control, deviations, and non-conformance processes within a regulated laboratory environment.The ideal candidate will demonstrate strong scientific judgment, excellent communication skills, and the ability to collaborate effectively with cross-functional teams and external clients. Subject matter expertise in inhalation product characterization, realistic APSD testing, and technical leadership in a regulated environment is highly desirable.What You'll Do:•Independently performs analytical method development/ optimization/ validation, and/or other specialty technologies studies OR method transfers for pharmaceutical compounds or equivalent levels of expertise.Designs and executes experiments independently for self and others.•Writes, reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.•Leads analytical (procedural and instrumental) troubleshooting sessions.•Assists business development group in technical sales and marketing, and presents posters at technical conferences.•Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.•Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.Education and Experience Requirements:•Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).Analytical experience must include analytical testing support for inhalation devices (pMDIs, DPIs, nebulizers, nasal sprays and novel devices) In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.Knowledge, Skills, Abilities:•Intermediate knowledge of general chemistry and separation science•Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDAguidance•Full knowledge of technical operating systems•Ability to independently optimize analytical methods•Ability to independently perform root cause analysis for method investigations•Proven technical writing skills•Proven problem solving and troubleshooting abilities•Effective written and oral communication skills as well as presentation skills•Time management and project management skills•Ability to mentor others on technical operating systems•Ability to independently review and understand project proposals/plans•Ability to work in a collaborative work environment with a teamWork Environment:Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:•Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.•Able to work upright and stationary and/or standing for typical working hours.•Able to lift and move objects up to 25 pounds.•Able to work in non-traditional work env
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