FSP - Scientist - Drug Product Analytical

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description This is a fully onsite role based at our customer’s site in San Diego, CA (Carmel Valley area). We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner. Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers’ organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies. As a Scientist you will provide hands-on analytical support for drug product formulation and process development of parenteral pharmaceutical products across preclinical and clinical development. Design, execute, and interpret analytical studies that enable formulation selection, stability assessment, process optimization, in-use and compatibility evaluations, and investigation of product quality attributes. Serve as a laboratory-based analytical scientist with extensive HPLC expertise, particularly reversed-phase HPLC and size-exclusion chromatography, working closely with formulation scientists to generate high-quality, decision-enabling data. Key responsibilities: Collaborate closely with Pharmaceutical Development, Analytical Development, Research/Discovery. Design and execute analytical testing to support preformulation, formulation screening and optimization, process development, container-closure compatibility, in-use studies, and phase-appropriate parenteral drug product development. Plan and execute scientifically rigorous studies, including stability and stress studies, to understand the impact of formulation composition and process parameters on drug product critical quality attributes. Perform routine and non-routine analytical testing of formulation and process-development samples, including assay/purity and degradation-product analysis by reversed-phase HPLC and aggregate/fragment analysis by size-exclusion chromatography (SEC). Execute, optimize, and troubleshoot fit-for-purpose analytical methods used to support formulation, stability, and process-development studies. Support laboratory investigations and troubleshooting of unexpected analytical results, method performance issues, and drug product stability or process-related observations. Operate, troubleshoot, and maintain HPLC/UPLC instrumentation and associated chromatography data systems; contribute to evaluation and implementation of analytical technologies needed to support parenteral drug product development. Prepare, review, and maintain laboratory notebooks, test methods, protocols, reports, data summaries, and other pharmaceutical development documentation with a high standard of scientific integrity and data quality. Analyze and trend analytical data, clearly communicate conclusions and limitations, and connect analytical results to formulation and process-development decisions. Manage laboratory organization, ordering consumables, and coordinating future lab buildout as necessary. May train colleagues on analytical methods, instrumentation, and laboratory procedures as appropriate. Perform other duties as assigned. Education and Experience: Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) OR Masters degree 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 and Abilities: Common Knowledge & Skills Demonstrates ability to work independently or as part of a team. Consistently identifies anomalous or inconsistent data, determines root cause, and implements scientifically sound solutions with minimal oversight. Demonstrates deep practical expertise in chromatographic analysis and applies analytical science to solve complex formulation, stability, and process-development problems. Strong command of scientific principles, methods, and techniques, with ability to translate theory into practical development solutions. Demonstrated proficiency with HPLC/UPLC systems and chromatography data analysis; able to troubleshoot chromatographic, instrument, sample-preparation, and method-performance issues independently. Strong analytical thinking and creative problem-solving skills in a cross-functional, matrix environment. Excellent written and verbal communication skills, including preparation of technical reports and delivery of scientific presentations to internal and external stakeholders. Detail-oriented while maintaining awareness of broader scientific, regulatory, and commercial implications. Demonstrates accountability for own work and project outcomes Job-Specific Knowledge & Qualifications Strong understanding of analytical laboratory practices, data integrity, and phase-appropriate GxP expectations supporting pharmaceutical development. Extensive hands-on HPLC experience is required, including reversed-phase chromatography for assay, purity, and degradation-product analysis and size-exclusion chromatography (SEC) for aggregate and/or fragment analysis. Hands-on experience supporting formulation, stability, or process-development studies for parenteral drug products is preferred. Experience interpreting chromatographic data and using analytical results to assess formulation and process effects, degradation pathways, product stability, and critical quality attributes. Experience with ion-exchange chromatography (IEX) is preferred but not required. Familiarity with complementary parenteral drug product characterization techniques such as pH, osmolality, SoloVPE, particulates (HIAC & MFI), cIEF, ceSDS, or other physicochemical methods is a plus. Experience generating, reviewing, and summarizing analytical data for development reports, stability programs, investigations, and CMC documentation is preferred. Working knowledge of ICH and regulatory expectations relevant to analytical testing, stability, and parenteral drug product development is a plus. Ability to prioritize work under tight timelines Worki