Job Summary:

The Mass Spectrometry Lab Manager is responsible for overseeing the operations of the Mass Spectrometry (MS) Lab within a cGMP analytical chemistry environment. This role involves establishing standard operating procedures (SOPs), developing methods, managing workflow, and ensuring the delivery of high-quality analytical testing services for OTC drug raw materials, finished products, pharmaceuticals, and other products using LC-MS and GC-MS techniques.

Key Responsibilities:

• Lab Management: Build and manage the MS lab’s workflow, personnel, and deliverables to ensure compliance with cGMP standards.
• SOP Development: Establish and document best practices, SOPs, 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 of various products.
• 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 (SME) for mass spectrometry, GC-MS, and LC-MS methodologies.
• Training: Train MS Lab Associate(s) 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 (OOS) 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. Alternatively, an MS with 10+ years of relevant experience will be considered, including 5+ years in a managerial role.
• Instrumentation Knowledge: Extensive experience with maintaining and troubleshooting a variety of 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.