Thermo Fisher Scientific · 12 hours ago
Research Scientist PI – Bioanalytical
United States
Full-time
Remote
Mid, Senior Level
3+ years expThermo Fisher Scientific is a leading global contract research organization committed to enabling customers to make the world healthier, safer, and cleaner. The Research Scientist acts as the sponsor representative/study monitor for clinical trials, overseeing exploratory sample shipment and analysis, ensuring data completeness, and maintaining comprehensive documentation of monitoring activities.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
No H1B
Responsibilities
Coordinates and oversees exploratory sample shipment and analysis to guarantee consistency and reliability in results
Reviews and verifies exploratory biomarker data to ensure completeness and support data transfer to Study Sponsor
Liaises with specialty laboratories to facilitate communication, address issues, and ensure alignment on study objectives and timelines
Critically reviews sample analysis plan
Reports and maintains comprehensive documentation of all monitoring activities, including assay performance data and any deviations
Identifies potential risks related to sample analysis and implement mitigation strategies
Regularly updates Study Sponsor team members on progress, challenges, and outcomes related to biomarker sample analysis activities
Any other tasks as deem appropriate for the conduct of the exploratory biomarker oversight
Qualification
Required
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
PhD in Immunology or Molecular Biology and previous experience in the field of life sciences that provides the knowledge, skills, and abilities to perform the job comparable to 3+ years OR Master's Degree and previous experience in the field of life sciences that provides the knowledge, skills, and abilities to perform the job comparable to 6+ years
Experience in managing outsourced activities at external vendors required
Strong working knowledge of several classes of biomarker techniques and analytical platforms (e.g., qPCR, NGS, IHC, FISH, MRI/PET/CT imaging, flow cytometry, LS/MS, ligand binding assays, enzymatic assays, etc.) required
Previous experience developing exploratory and/or diagnostic biomarkers assays including study design, method validation, and reporting required
Expert knowledge of biomarker analytical data analysis and reporting required
Strong working knowledge of GCP/GCLP guidelines and other current global regulations required
Strong working knowledge of assay validation requirements for Phase I/II clinical trials required
Previous experience characterizing the pharmacological effects using biomarker assays
Previous experience defining the context of use (COU) and data analysis strategy for biomarkers
Previous experience translating biomarker assay applicability to all clinical trial phases
Extensive experience collaborating with independent stakeholders including escalation, risk management, and confidentiality management
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
Able to work upright and stationary for typical working hours
Ability to use and learn standard office equipment and technology with proficiency
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
Benefits
Full-time benefits
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Daniella Cramp
Senior Vice President and President, Bioproduction Group
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