Associate Scientist (LC/MS)
Job Description
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.
Responsibilities:
- 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.
Qualifications:
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.
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