The Mass Spectrometry Laboratory Scientist is responsible for independently executing established LC-MS and GC-MS analytical methods, processes, and procedures for the preparation and analysis of samples from OTC drug, Pharmaceutical, and Cosmetic industry clients.

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Reports to:

Mass Spectrometry Laboratory Manager

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Collaborates with:

Chemistry Laboratory and Quality Assurance Associates

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ROLES & RESPONSIBILITIES

• Operate, maintain, and troubleshoot LC-MS and GC-MS mass spectrometry instruments

• Perform routine sample preparation for LC-MS and GC-MS analysis (extractions, digestions, derivatizations, dilutions).

• Conduct quantitative and qualitative analysis of pharmaceuticals and other compounds.

• Participate in development and validation of MS-based analytical methods following regulatory and scientific guidelines (ICH, FDA, USP).

• Process, interpret, and report experimental data with accuracy and clarity.

• Ensure data integrity and compliance with GLP/GMP, 21 CFR Part 11, and internal SOPs.

• Maintain lab documentation (logbooks, electronic records, method development reports).

• Collaborate with cross-functional teams.

• Assist in instrument qualification, calibration, and preventive maintenance.

• Stay current with advances in mass spectrometry t

• echnologies and workflows.

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TECHNICAL SKILLS

• Strong knowledge of LC-MS and GC-MS operation and applications. Experience with LC-MS/MS a plus.

• Broad experience in sample preparation techniques for LC-MS and GC-MS analysis.

• Familiarity with MS software for data acquisition and analysis. Familiarity with Waters and Agilent instrumentation and software a plus.

• Thorough understanding of chromatographic separation.

• Experience with impurity and/or contaminant profiling methods such as nitrosamines, extractables & leachables, pesticides, residual solvents, API impurities, and/or PFAS desirable

• Strong understanding of analytical method development and validation principles.

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REQUIREMENTS

• PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or related fields may be preferred.

• Masters degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related fields with 4-6 years experience or Bachelors degree with 6-10 years hands-on experience with LC-MS and GC-MS instruments and methods may be accepted.

• Hands-on experience in sample analysis and instrument operation required.

• Experience working in an FDA-regulated environment, preferably cGMP highly desired

• Must be permitted to work in the US.

• This is a 100% onsite position.

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