Mass Spectrometry Lab Manager

3 months ago

South Plainfield, United States Medix™ Full time

Roles & Responsibilities

  • Build and manage the mass spectrometry (MS) lab, overseeing workflow, personnel, and deliverables in a cGMP-compliant analytical laboratory using LC-MS and GC-MS for testing OTC drugs, dietary supplements, cosmetics, and Rx Pharma products.
  • Establish best practices, SOPs, work processes, workflow, and reporting templates for the MS Lab.
  • Develop and validate mass spectrometry and chromatography parameters and methods for LC-MS and GC-MS quantitation of desired analytes.
  • Write and review standard operating procedures, and coordinate method development and validation of MS analytical methods.
  • Serve as the subject matter expert (SME) for mass spectrometry, GC-MS, and LC-MS.
  • Train MS Lab Associates in new methods, instrumentation, and standard operating procedures.
  • Oversee daily operations, ensuring timely deliverables from the MS Lab.
  • Identify and engage the best vendors for equipment, reagents, and disposables to establish and maintain LC-MS, GC-MS, and other MS Lab capabilities.
  • Coordinate and support IQ/OQ/PQ, calibration, and maintenance of MS laboratory equipment and instrumentation.
  • Produce high-quality data across multiple MS methods and platforms, and perform daily quality control reviews of lab results.
  • Represent the MS Lab in internal audits, client audits, and regulatory inspections.
  • Hire, train, and manage MS Lab staff, including conducting annual reviews.
  • Lead troubleshooting efforts for all MS Lab issues, conduct investigations for out-of-specification (OOS) results, and manage deviations related to MS procedures.
  • Maintain and troubleshoot GC-MS, LC-MS, and other MS Lab equipment.


Requirements

  • PhD in Chemistry preferred; other Life Sciences degrees acceptable, with 5+ years of MS Lab experience, including significant people and process responsibility, preferably in an FDA cGMP-regulated environment.
  • MS with 10+ years of experience will be considered, with at least 5 years managing people and developing methods for GC-MS and LC-MS instruments in an FDA cGMP-regulated environment.
  • Experience in maintaining and troubleshooting a wide range of analytical lab instruments, with deep knowledge of single quadrupole, triple quadrupole, and advanced MS instruments interfaced with both LC and GC separation platforms.
  • Proficiency in a broad array of analytical services, including basic quantitation and potency testing, residual solvents, extractables & leachables, nitrosamines, pesticides, bioanalytical, pharmacokinetics, and metabolism studies.
  • Proven ability to work independently, build programs and platforms, and solve problems.
  • Demonstrated capability to work effectively in high-stress, rapid-growth environments.
  • Excellent people, communication, and leadership skills.
  • Ability to prioritize routine tasks and adapt to changing environments.

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