FSP - Scientist - Drug Product Analytical

About the role

This is a fully onsite Scientist position located at our customer’s site in San Diego, CA (Carmel Valley area). The role follows a standard Monday‑to‑Friday work schedule and requires working in a laboratory setting with appropriate personal protective equipment (safety glasses, gowning, gloves, lab coat, ear plugs, etc.). Candidates must be legally authorized to work in the United States without sponsorship and able to pass a comprehensive background check, including drug screening. Relocation assistance is not provided. At Thermo Fisher Scientific you will contribute to meaningful work that enables customers to make the world healthier, cleaner, and safer, supporting the Laboratories Functional Service Partnership (FSP) team in advancing drug development through sustained, high‑quality analytical support.

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 a similar field.
• Scientist level: Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 2+ years) OR a Master's degree.
• In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience will be considered sufficient.

Skills

• 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.
• Deep practical expertise in chromatographic analysis and applying 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.
• Strong understanding of analytical laboratory practices, data integrity, and phase‑appropriate GxP expectations supporting pharmaceutical development.
• Extensive hands‑on HPLC experience, 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.

Benefits

• Competitive remuneration and annual incentive plan bonus.
• Healthcare: choice of national medical and dental plans, national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours paid time off (PTO) per year.
• 10 paid holidays annually.
• Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave).
• Accident and life insurance.
• Short‑ and long‑term disability coverage.
• Retirement and savings programs, such as a competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP) offering eligible colleagues the opportunity to purchase company stock at a discount.
• For more details on benefits, see the Total Rewards page: https://jobs.thermofisher.com/global/en/total-rewards.

Pay

The hourly pay range estimated for this position based in California is $31.00–$38.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

Schedule

Work Schedule: Standard (Monday‑Friday).