Laboratory Operations Manager

1 day ago


East Brunswick, New Jersey, United States Kelly Science, Engineering, Technology & Telecom Full time

Job Summary:

The Kelly Science, Engineering, Technology & Telecom Mass Spectrometry Lab Manager oversees daily operations of the Mass Spectrometry Lab within a cGMP analytical chemistry environment. This role involves developing standard operating procedures, managing workflow, and ensuring high-quality analytical services for various products using LC-MS and GC-MS techniques.

Key Responsibilities:

  • Lab Management: Manage lab personnel, workflow, and deliverables to ensure compliance with cGMP standards.
  • SOP Development: Establish and document best practices, standard operating procedures, and work processes to streamline lab operations.
  • Method Development: Develop, validate, and optimize mass spectrometry and chromatography methods for LC-MS and GC-MS analysis.
  • Documentation: Write, review, and coordinate the development and validation of MS analytical methods and associated documentation.
  • Subject Matter Expertise: Serve as the subject matter expert for mass spectrometry, GC-MS, and LC-MS methodologies.
  • Training: Train MS Lab Associates in new methods, instrumentation, and SOPs.
  • Operational Oversight: Oversee daily laboratory operations to ensure timely and accurate deliverables.
  • Vendor Management: Identify and establish relationships with vendors for lab equipment, reagents, and supplies necessary for MS operations.
  • Equipment Calibration: Coordinate IQ/OQ/PQ, calibration, and maintenance of MS laboratory equipment.
  • Data Quality Assurance: Produce and review quality data for testing results across multiple MS methods and platforms.
  • Audit Representation: Represent the MS Lab in internal, client, and regulatory audits.
  • Staff Management: Hire, train, and conduct annual reviews for MS Lab staff.
  • Troubleshooting: Lead troubleshooting efforts for MS Lab issues and manage investigations for out-of-specification results.
  • Equipment Maintenance: Maintain and troubleshoot GC-MS, LC-MS, and other analytical instrumentation.

Requirements:

  • Experience: Minimum of 5+ years of mass spectrometry lab experience with significant responsibility in people and processes, preferably in an FDA cGMP-regulated environment.
  • Instrumentation Knowledge: Extensive experience with maintaining and troubleshooting various analytical lab instruments, including single quadrupole and triple quadrupole mass spectrometers interfaced with LC and GC systems.
  • Analytical Expertise: Proficient in a broad range of analytical services such as quantitation, potency testing, residual solvents analysis, and more.
  • Independent Worker: Proven ability to work independently, develop programs, and solve complex problems.
  • Adaptability: Capacity to work in a high-stress, rapid growth environment and adapt to changing priorities.
  • Interpersonal Skills: Excellent communication, leadership, and team management skills.

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