FSP - Scientist - Sample Management

<p style="text-align:left"><b>Work Schedule</b></p>Standard (Mon-Fri)<p style="text-align:inherit"></p><p style="text-align:left"><b>Environmental Conditions</b></p>Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p><p>Shift: Full-Time; Monday – Friday; 8am-5pm EST</p><p>This is a fully onsite role based at our customer’s site in <b><i>Collegeville, PA.</i></b> 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.  </p><p>Must be legally authorized to work in the United States without sponsorship. </p><p>Must be able to pass a comprehensive background check, which includes a drug screening. </p><p>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&#43; 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.</p><p>Thermo Fisher&#39;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.</p><p>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.</p><p><b>Key responsibilities:</b></p><p>The Scientist oversees the lifecycle of clinical samples, ensuring their accurate and compliant management to support clinical and bioanalytical activities. This role involves handling sample receipt, storage, transfer, documentation, and disposal in alignment with regulatory and ethical standards.</p><ul><li>Sample handling and inventory management: The role includes laboratory tasks such as receiving clinical samples, importing manifests into the Laboratory Information Management System (LIMS), and maintaining sample inventory control and reconciliation. Samples are stored in qualified units according to study and SOP requirements.</li><li>Sample tracking and coordination: Accurate tracking of sample locations, status, and conditions is maintained within the LIMS. The manager coordinates sample transfers to internal analysts, ensuring traceability and chain of custody, and aligns sample movements with study timelines and analytical needs.</li><li>Compliance, documentation, and stakeholder communication: All sample management activities are documented timely and accurately to support inspection readiness under Good Clinical Practice (GCP). The manager liaises with clinical teams, sites, and external organizations, ensures compliance with ethical and regulatory requirements, supports audits, and adheres to health, safety, and environmental protocols.</li></ul><p><b>Education and Experience: </b></p><ul><li>Bachelor&#39;s degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar</li><li>Previous experience that provides the knowledge, skills, and abilities to perform the job <b>(comparable to 2-4 years’)</b></li><li>Or a Master’s degree and previous experience that provides the knowledge, skills, and abilities to perform the job <b>(comparable to 0-2 years’)</b></li></ul><p>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.</p><p><b>Knowledge, Skills and Abilities: </b></p><ul><li>Experience supporting clinical studies in a regulated (GCP) laboratory, biobanking, or sample management environment.</li><li>Hands‑on experience with enterprise sample management LIMS platforms (e.g., Watson LIMS or equivalent).</li><li>Familiarity with end‑to‑end clinical sample lifecycle management, including long‑term storage, biobanking, and sample disposition.</li><li>Experience working in an inspection‑ready environment, including exposure to audits or inspections (e.g., FDA, MHRA, internal QA).</li><li>Understanding of data integrity principles (e.g., ALCOA&#43;) as applied to clinical sample documentation and electronic systems.</li><li>Demonstrated experience performing clinical sample management activities within a laboratory environment, including sample receipt, inventory management, storage, transfer, and disposal.</li><li>Proven experience using a sample management Laboratory Information Management System (LIMS) to enter, maintain, and reconcile sample data, including sample manifests and randomization information.</li><li>Working knowledge of Good Clinical Practice (GCP) requirements as they apply to clinical sample handling, documentation, and traceability.</li><li>Experience performing work in compliance with applicable ethical and regulatory requirements, relevant government regulations, and controlled Standard Operating Procedures (SOPs).</li><li>Demonstrated ability to maintain accurate documentation, sample traceability, and chain of custody to support inspection readiness.</li><li>Experience interfacing with laboratory analysts, clinical study teams, clinical sites, and/or contract research organizations in support of clinical studies.</li><li>Demonstrated commitment to safe working practices and adherence to laboratory health and safety requirements.</li></ul><p></p><p><b>Working Environment: </b></p><p>Below is listed the working environment/requirements for this role:</p><p>Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.</p><p>Able to work upright and stationary and/or standing for typical working hours.</p><p>Able to lift and move objects up to 25 pounds</p><p>Able to work in non-traditional work environments.</p><p>Able to use and learn standard office equipment and technology with</p><p>proficiency.</p><p>May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.</p><p>Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.</p><p><b>Benefits</b></p><p>We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!</p><p></p><p></p><p></p><p></p><p></p>