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 focused on method development, optimization, validation, sample analysis, troubleshooting, data review, and documentation for analytes including lipids, biomarkers, proteins, and peptides.
location: Norwood, Massachusetts
job type: Contract
salary: $45.00 - 54.19 per hour
work hours: 9 to 5
education: Bachelors
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)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
