FSP Senior Scientist-Scientific Writer

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description This is a fully onsite role based at our customer’s site in Collegeville, PA 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. Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. Summarized Purpose: Testing of clinical biological samples for various biomarkers using immunoassay platforms (MSD, Quanterix, etc.) in a GCP compliant environment. Essential Functions: Develop and validate immunoassay methods to support clinical biomarker endpoints. Prepare regulated documents, including validation plans and reports, analytical reports, and SOPs. Perform routine testing of clinical biological samples (primarily serum) to support biomarker analysis using validated immunoassay methods in a Good Clinical Practice (GCP) compliant laboratory. Execute assays on immunoassay platforms such as Meso Scale Discovery (MSD) and similar technologies (e.g., Quanterix), following established standard operating procedures (SOPs). Prepare, handle, and process clinical samples in accordance with laboratory safety procedures and biohazard handling guidelines. Conduct testing using validated methods with minimal method development responsibilities, ensuring data quality, accuracy, and adherence to study timelines. Document all laboratory activities clearly and contemporaneously in compliance with GCP, internal quality standards, and regulatory requirements. Review assay results for accuracy and completeness; identify routine technical issues and escalate concerns appropriately. Support clinical study workflows including sample receipt, tracking, preparation, analysis, and data reporting. Assist with assay validation activities and laboratory investigations as assigned. Maintain laboratory equipment, reagents, and consumables to ensure operational readiness and inspection readiness. Collaborate with team members to meet project milestones and contribute to a compliant, organized laboratory environment. Education and Experience: Bachelor's degree in related area with 2+ years of experience in a regulated bioanalytical laboratory. 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: Immunoassay experience and experience with Watson LIMS preferred. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthrough.