FSP - Scientist - Drug Product Analytical

Work Schedule

Environmental Conditions

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…