Senior Scientist – ELISA / LBA / Biomarker

Work Schedule First Shift (Days) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting Job Description Senior Scientist – ELISA / LBA / Biomarker Position: Shift: Full-Time; Monday – Friday; 8am-5pm EST ONSITE: This is a fully onsite role based at our customer’s site in (Boston, MA). 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.

Prior hands-on experience developing ligand binding assays for translational or clinical applications. Experience developing and validating assays, with working knowledge of assay validation expectations and fit-for-purpose principles. Design and execute method development activities for innovative biomarker assays intended for use as primary, secondary, or exploratory endpoints in clinical trials. Evaluate assay feasibility and strategies for the measurement of novel biomarkers in relevant biological matrices, including human biofluids and tissues. Collaborate with senior members of the Biomarkers group and cross-functional partners to develop, optimize, and implement high-quality biomarker assays. Apply knowledge of biomarkers, translational medicine, and assay validation principles to design robust assays suitable for clinical trial use and aligned with regulatory expectations, including FDA requirements. Perform mock validation experiments and contribute to generation of data packages supporting assay readiness. Support assay transfer activities to CROs and external laboratories, including technical handoff and troubleshooting as needed. Analyze, interpret, and clearly communicate experimental results to internal stakeholders and project teams. Present data at team and project meetings as needed Education and Experience: Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’) OR Masters degree and previous experience that provides the knowledge,