FSP Senior Scientist - Precision Medicine

Thermo Fisher Scientific•Lawrenceville, NJ

1d•$82,000 - $87,000

About The Position

The Senior Scientist, Precision Medicine is a hands-on scientist responsible for day-to-day execution of local testing and other in vitro diagnostic operations supporting clinical trials. Working under Precision Medicine leadership and in partnership with study teams, Clinical Operations, Biospecimen Leads, testing laboratories, and external diagnostic partners, this role manages operational workstreams that support timely and accurate patient eligibility testing and diagnostic development and regulatory studies. The role reviews local test assessments, monitors concordance between local and central results, reconciles data, supports biospecimen planning, and coordinates diagnostic partners and laboratories. It maintains operational continuity and helps expand the capacity of the Precision Medicine organization. Work is performed in a laboratory and/or clinical environment, with occasional drives to site locations and occasional domestic travel. The position involves potential exposure to biological fluids and infectious organisms, and rare exposure to irritants, radiation, toxic materials, hazardous waste, and temperature extremes. Required personal protective equipment may include protective eyewear, garments, and gloves. The role requires extended stationary or upright work, repetitive hand movements to operate laboratory equipment, occasional mobility, frequent upper-body bending and twisting, and light to moderate lifting of up to 15–20 pounds. It also involves computer use, communication and collaboration, independent planning, multitasking, and periods of intense concentration.

Requirements

Bachelor’s degree or equivalent formal academic qualification in a relevant scientific or technical discipline, such as Biology or Chemistry.
4–6 years of experience supporting laboratory operations or a related function; a combination of education, training, and directly related experience may be considered in lieu of formal requirements.
At least 1–3 years of experience in biomarker or in vitro diagnostic assay development, validation, or clinical testing in a pharmaceutical, diagnostic, or clinical laboratory setting.
Working knowledge of biomarker or in vitro diagnostic platforms such as IHC, NGS, PCR, or immunoassay.
Ability to work effectively as a member of a multidisciplinary matrix team and manage multiple concurrent programs with strong attention to detail.
Comprehensive knowledge of principles, concepts, and/or methodologies within drug discovery, development, or production.
Ability to work upright and/or stationary for 6–8 hours per day and perform repetitive hand movements to operate laboratory equipment.
Ability to occasionally crouch or stoop, frequently bend and twist the upper body and neck, and lift or carry objects weighing up to 15–20 pounds.
Ability to access and use in-house and off-the-shelf computer software.
Ability to communicate and understand information presented verbally, interact with diverse groups, work independently with little guidance, plan work schedules, multitask, and perform under stress.
Regular and consistent attendance.
Adherence to Good Manufacturing Practices (GMP) safety standards.
Ability to use required personal protective equipment in laboratory or clinical environments.

Responsibilities

Serve as primary or backup reviewer for local test assessments supporting clinical trial eligibility, evaluating laboratory assays against protocols and Precision Medicine local test approval requirements.
Own local testing workflows, including laboratory onboarding documentation, approval tracking, and communication of decisions to study teams, Clinical Operations, and sites.
Lead concordance monitoring between local and central test results and reconcile data across clinical, central laboratory, and diagnostic partner datasets; identify and escalate discordance trends and data quality issues with recommended actions.
Serve as the Precision Medicine point of contact for biospecimen planning on assigned programs, partnering with Biospecimen Leads and Clinical Operations to support sample availability, appropriate consent and sample use, and inventory tracking.
Coordinate operational activities with external diagnostic partners and testing laboratories, including validation sample transfers, testing status, data transfers, and issue resolution; track partner deliverables against program milestones.
Maintain program trackers and documentation, including testing status, sample inventories, and partner timelines.