Principal Research Associate, Bioanalytical and Molecular Assays

About the role

The Bioanalytical and Molecular Assay team is seeking an experienced, hands-on Principal Research Associate contractor to support regulated bioanalytical LC‑MS/MS activities for clinical studies. This is an internal, laboratory‑based role located in Norwood, Massachusetts, focused on method development, optimization, validation, sample analysis, troubleshooting, data review, and documentation for analytes including lipids, biomarkers, proteins, and peptides.

Responsibilities

• Develop, optimize, validate, and execute quantitative LC‑MS/MS bioanalytical methods.
• Perform sample preparation from biological matrices using protein precipitation, SPE, LLE, enzymatic digestion, and related techniques.
• Conduct clinical sample analysis according to approved methods, protocols, SOPs, and applicable GLP/GCP requirements.
• Operate and troubleshoot LC‑MS/MS systems, chromatography, sample‑preparation workflows, and data‑processing issues.
• Process, analyze, and review calibration standards, QCs, and study samples against established acceptance criteria.
• Perform data processing and review using LC‑MS software platforms such as SCIEX software and Thermo Scientific Xcalibur.
• Use Watson LIMS and electronic laboratory systems for sample tracking, run management, data review, and study documentation.
• Document experiments, deviations, investigations, and results in ELN/LIMS systems.
• Draft or contribute to bioanalytical methods, validation protocols, study plans, SOPs, and technical/study reports.
• Collaborate with internal cross‑functional teams and provide LC‑MS/MS technical support as needed.
• Support high‑throughput or semi‑automated sample preparation and data‑analysis workflows where applicable.
• Maintain awareness of applicable regulatory guidance, internal procedures, and industry best practices for regulated bioanalysis.

Qualifications

• BS with 5+ years or MS with 3+ years of relevant hands‑on bioanalytical LC‑MS/MS experience.
• Demonstrated experience in LC‑MS/MS method development, optimization, validation, and regulated sample analysis.
• Strong experience with biological sample preparation and quantitative bioanalysis.
• Experience with lipids, biomarkers, proteins, peptides, and/or other relevant analytes.
• Working knowledge of GLP/GCP and regulated bioanalytical practices.
• Hands‑on experience with LC‑MS/MS data acquisition and processing software, preferably SCIEX platforms/software and Thermo Scientific Xcalibur.
• Experience with Watson LIMS for regulated bioanalytical sample and data management is strongly preferred.
• Experience with ELN and other laboratory data‑management systems.
• Ability to independently plan and execute laboratory work, troubleshoot technical issues, and manage multiple priorities.
• Strong attention to detail, documentation, organization, communication, and collaboration skills.
• Experience with Hamilton automation is preferred.
• Prior experience working in a CRO or regulated bioanalytical laboratory environment is a plus.

Skills

• Chromatography
• Laboratory Information Management Systems (LIMS)
• Liquid Chromatography (LC)
• Mass Spectrometry (MS)
• Good Laboratory Practices (GLP)
• Good Clinical Practice (GCP)

Benefits

• Medical insurance
• Prescription coverage
• Dental insurance
• Vision insurance
• AD&D insurance
• Life insurance
• Short‑term disability
• 401K plan

Pay

Salary range: $45.00 – $54.19 per hour.

Schedule

Work hours: 9 to 5.