FSP Senior Scientist-Scientific Writer

This is a fully onsite role based at our customer’s site in Collegeville, PA. We welcome applicants from all locations within the US. Relocation assistance is not provided; any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship and able to pass a comprehensive background check, including a drug screening.

About the role

Within our Analytical Services team, we offer a functional service provider solution—a unique partnership that allows our customers to leverage the experience of our staff while providing you direct experience working onsite at a pharmaceutical/biopharmaceutical company, all while maintaining full-time benefits.

This role involves testing clinical biological samples for various biomarkers using immunoassay platforms (MSD, Quanterix, etc.) in a GCP-compliant environment.

Responsibilities

• 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.

Requirements

• Bachelor's degree in a 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 may be considered.
• Immunoassay experience and experience with Watson LIMS preferred.

Schedule

Standard (Mon-Fri)

Environmental Conditions

Office and laboratory setting.

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 in delivering life-changing therapies and improving health outcomes worldwide.