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Senior Research Scientist - Extractables/Leachables (LCMS & GCMS)

Thermo Fisher Scientific
United Statesfull_timeVerifiedPosted 25 Sept 2025

About the role

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

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.

Location/Division Specific Information

One of the largest in-house teams dedicated to preference elicitation and related decision analysis. Our clients include all major pharmaceutical and medical device manufacturers globally. Our work enables these clients to understand which treatment or device attributes are meaningful to patients, how patients trade-off across these attributes, and what are the implications of such patient preference data for decisions that include regulatory approval and reimbursement of medicines. We specialize in the application of stated preference techniques, such as discrete choice experiment, best worst scaling and swing weighting.

You would be joining a fast growing, successful team, operating at the cutting edge of the science of incorporating stakeholder preferences into health care decision making. We have developed an innovative, collaborative culture, aimed at developing and sharing good practice in preference research, both internally and externally. We are looking for someone who will thrive in this environment.

Discover Impactful Work:

The Senior Research Scientist is responsible for the scientific scope, accuracy and regulatory alignment for method feasibility, development, and validation.  Provides technical and regulatory consulting and oversight for internal groups and clients regarding method establishment programs.  Oversees troubleshooting on multiple analytical instruments and multiple detection techniques, data calculation and interpretation, and records data in adherence with Thermo Fisher Scientific, Inc. SOPs and any additional requirements specific to the lab and / or client. Provides mentorship and technical guidance to scientific staff, acting as program lead to provide updates and reports for multiple clients, and collaborating with lab leaders to ensure client needs are met. The position also focuses on implementing strategies for project profitability and long-term quality improvements.

Key Responsibilities

  • Train, mentor, and coach technical staff, translating extractables/leachables proposal scope to testing needs and guiding project closure and transition into routine leachable testing.
  • Mentor analytical staff on technical writing, study design, and efficient testing,
  • fostering independent test execution and troubleshooting.
  • Leverage expertise in method establishment to support project execution on multiple Lcms and GCMS technologies internally and with clients.
  • Drive business decisions and process improvements as a technical expert and execute new strategies for technical advancement.
  • Develop staff identified by lab leaders (TOMs) as candidates for method establishment project work.
  • Identify roadblocks and implement strategies during method establishment that positively impact downstream routine work (method life cycle management).
  • Function as the technical point of contact for overall client relationship for method establishment work, providing guidance or recommendations to clients based on the phase of work and long-term testing needs and strategies.
  • Communicate project plans, updates, and technical issues to clients, ensuring clear and respectful communication.
  • Drive risk assessments, advise clients on regulatory guidance, and recommend risk mitigation strategies.
  • Manage overall client portfolio for method establishment testing (timelines, expectations, quality).
  • Drive client growth by expanding relationshi

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Company

Thermo Fisher Scientific

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