Senior Scientist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Position: Senior Scientist

ONSITE:

This is a fully onsite role based at our customer’s site in (Gaithersburg, Maryland). 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.

Key responsibilities:

• This candidate will deliver ligand-binding testing associated with departmental pharmacokinetic (PK) and pharmacodynamic (PD) studies. This is a hands-on, laboratory-based assignment focused on timely sample analysis and generation of accurate, traceable, fit-for-purpose bioanalytical data.

• Candidate will work to develop or work from approved methods, protocols, study plans, and departmental procedures; coordinate testing priorities with designated scientific leads; and independently

• execute routine assay activities. Work may include assay readiness checks, reagent and sample preparation, plate execution, data review, repeat analysis when scientifically justified, and preparation of study-level data packages.

• The assignment is delivery-oriented. They are expected to manage agreed work efficiently, escalate risks promptly, and maintain complete records sufficient for scientific review and downstream reporting. Final priorities, study volume, and schedules will be set by the department based on portfolio needs.
• Develop and/or Execute ligand-binding assays for PK and PD sample testing using established methods and approved study documentation. Additional responsibilities for assay delivery may be assigned in accordance with department needs (e.g. flow cytometry assay development and/or testing if applicable).

• Prepare samples, standards, controls, reagents, and assay plates; operate applicable laboratory instrumentation and software.

• Complete assay readiness activities, including reagent checks, control evaluation, and method familiarization or training.

• Review run performance against predefined acceptance criteria and identify, document, and communicate assay issues or deviations.

• Perform scientifically justified repeat analysis and basic troubleshooting in consultation with the designated scientific lead.

• Analyze and process data using approved templates and systems, ensuring accuracy, traceability, and appropriate quality control.

• Maintain contemporaneous records in electronic laboratory notebooks, sample-management systems, and other departmental repositories.

• Prepare complete data packages, summaries, and supporting documentation for scientific review and reporting.

• Track assigned workload, turnaround times, and dependencies; provide concise status updates and escalate delivery risks promptly.

• Follow applicable safety, biosafety, data-integrity, confidentiality, and departmental procedures.

• Coordinate effectively with project scientists, sample-management colleagues, and other internal partners.

Education and Experience:

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) OR Masters degree

Knowledge, Skills and Abilities:

• Experience testing nonclinical or clinical study samples in a pharmaceutical, biotechnology, or contract research environment.

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