Laboratory Operations Manager
1 day ago
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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