| Location | Mansfield, MA |
| Job Type | Contractor |
| Salary | $55–$60 Per Hour |
We are seeking an experienced Scientist – Mass Spectrometry Specialist with advanced expertise in mass spectrometry instrumentation, analytical method execution, and complex data interpretation. The ideal candidate will have 5–7 years of experience in pharmaceutical quality control and analytical laboratory testing within a regulated GMP environment, with strong hands-on experience in LC-MS and/or GC-MS.
The successful candidate will support pharmaceutical characterization, impurity identification, investigative testing, analytical method execution, instrument troubleshooting, and data interpretation, while ensuring compliance with GMP, data integrity, and applicable regulatory requirements.
Operate, maintain, troubleshoot, and optimize Mass Spectrometry instrumentation and associated analytical systems.
Perform analytical testing using LC-MS, GC-MS, and other relevant mass spectrometry platforms.
Execute approved analytical methods and protocols for pharmaceutical testing and characterization.
Interpret complex mass spectral and chromatographic data to support scientific and quality-related investigations.
Support pharmaceutical characterization and impurity identification, including identification and evaluation of unknown or unexpected components.
Conduct investigative testing to support OOS/OOT results, deviations, product investigations, and analytical troubleshooting.
Develop, optimize, or assist with analytical methods involving chromatographic and mass spectrometric techniques, as applicable.
Evaluate mass spectra, chromatograms, extracted ion chromatograms, and other analytical data for accuracy and scientific relevance.
Review analytical data, calculations, instrument records, and laboratory documentation for completeness and compliance.
Perform instrument troubleshooting and coordinate maintenance or service activities when required.
Support product release, stability, characterization, and investigative testing programs, as applicable.
Maintain accurate laboratory records in accordance with GMP, SOPs, and data integrity requirements.
Ensure proper handling and documentation of samples, standards, reagents, and reference materials.
Participate in laboratory investigations and provide technical input for root-cause assessments.
Support regulatory inspections and internal/external audits by providing technical documentation and analytical information.
Collaborate with Quality Assurance, QC, R&D, Manufacturing, and other cross-functional teams.
Maintain laboratory readiness and ensure analytical activities are completed accurately and within established timelines.
Bachelor’s or Master’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline.
5–7 years of experience in pharmaceutical quality control and analytical laboratory testing.
Experience working within a regulated GMP environment.
Advanced hands-on experience operating and troubleshooting Mass Spectrometry instrumentation.
Strong experience with one or more of the following: LC-MS, GC-MS, LC-MS/MS, or related MS platforms.
Demonstrated experience in analytical method execution, data interpretation, pharmaceutical characterization, and impurity identification.
Experience supporting investigative testing, analytical troubleshooting, OOS/OOT investigations, or product-related investigations.
Strong understanding of pharmaceutical analytical testing methodologies and chromatographic techniques.
Knowledge of GMP, data integrity, ALCOA+ principles, and laboratory documentation practices.
Ability to independently execute analytical testing and critically evaluate complex analytical data.
Strong scientific problem-solving and troubleshooting capabilities.
Excellent attention to detail and commitment to quality and compliance.