Associate Scientist (LC/MS)

Quest Diagnostics • Full-time • Chantilly, Virginia, United States • $59.38k - $86.56k / year • 1d ago

The Associate Scientist will support research and development projects within the LC-MS/MS and Radioimmunoassay Department. This role will focus on the development, transfer, optimization, and validation of diagnostic assays utilizing LC-MS/MS and ELISA. The ideal candidate will possess a strong background in analytical chemistry, biochemistry, or a related field, with hands-on experience in bioanalytical methods, instrument operation, and clinical assay development. The Associate Scientist will collaborate with senior scientists, technologists, and cross-functional teams (operation, QA, IT, etc.) to advance new and existing diagnostic assays into clinical operations.

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Perform research and development of LC-MS/MS-based clinical diagnostic assays, including method development, optimization, troubleshooting, and validation in compliance with CLIA/CAP and Quest Diagnostics requirements.
Support ELISA and radioimmunoassay development, including reagent/kit evaluation, assay optimization, and validation.
Conduct analytical experiments (sample preparation, extraction, separation, and detection) for vitamins, steroids, peptides, and protein biomarkers.
Operate and maintain LC-MS/MS instruments (e.g., Thermo TSQ/ Altis Plus, Shimadzu 8060NX/RX, Sciex 5500/6500, Hamilton Star, TECAN, etc.) and immunoassay platforms; ensure accurate instrument calibration and system suitability.
Analyze and interpret experimental data, document results in laboratory notebooks, technical reports, and validation documents.
Assist in the transfer of new assays from R&D to clinical operations, ensuring robustness and reproducibility.
Contribute to quality improvement initiatives, process optimization, and instrument replacement/upgrade projects.
Contribute to cost saving initiatives, identify opportunities for cost saving.
Collaborate with other scientists and technologists to meet project timelines and deliverables.
Troubleshoot assay and instrument issues and support daily operation.
Partner with Operations for assay go-live readiness.
Partner with QA/Regulatory for documentation control.
Partner with Supply Chain for critical reagents/consumables.
Partner with Database /IT for LIS/interface integration.
Provide training and refreshments to technologists in operation and assist with assay go-live.

Required Education & Experience

BS in Chemistry, Biochemistry, Analytical Chemistry, Clinical Laboratory Science, or related field with 2–4 years hands-on LC-MS/MS experience in a regulated clinical and/or biopharma environment; OR
MS or Ph.D. in related field with 1–2 years relevant lab experience. Demonstrated participation in at least one full assay lifecycle (development validation transfer
post go-live monitoring) for either LC-MS/MS or ELISA/RIA is a plus.

Technical Knowledge

Solid understanding of LC-MS/MS quantitation method (separation/chromatography, ionization, MRM/SRM, isotope internal standards, matrix effects, calibration models, etc.).
Sample prep techniques: protein precipitation, LLE, SPE, derivatization (as applicable), immunoprecipitation, and enzymatic digestion, etc.
Understanding of ELISA fundamentals is a plus: antibody pairing, curve fitting, control system, plate reader operation.
Familiarity with CLIA/CAP requirements and CLSI guidelines for analytical method validation and change control.
Proficiency with instrument/vendor software (e.g., Trace Finder, Analyst/Sciex OS, LabSolutions), plate readers, and LIS/ELN basics.
Data handling: Excel and basic statistics for validation summaries (bias, CV, total error, Bland-Altman/Deming helpful). Ability to analyze, interpret, and clearly present validation data with appropriate statistics and acceptance criteria is required.
Exceptional communication and presentation skills.
Time/project management: plan experiments, manage timelines/milestones, and prioritize and execute multiple studies in parallel.
Quality mindset: adherence to safety and compliance; continuous improvement orientation aligned with the Quest “5 Cs.”
Documentation: write clear SOPs, work instructions, validation plans/reports; version control discipline.
Problem-solving: structured troubleshooting of assay and instrument issues; root-cause analysis mindset.