Mass Spectrometry Lab Manager- Immediate Opportunity in South Plainfield

We are an analytical testing laboratory with over 36 years of industry experience. They provide a comprehensive range of analytical laboratory services to the pharmaceutical, nutraceutical, and cosmetic industries.

Our mission is to be the complete solution for the biopharmaceutical industry’s Analytical Testing and Research and Development needs. The team prides itself on staying informed and ahead of the changing regulatory landscape. They pledge to serve their clients by providing them with accurate results, in an expeditious manner, with competitive pricing for their formulation, testing, and research and development needs.

The Mass Spectrometry (MS) Lab Manager is responsible for establishing standard operating procedures (SOPs), developing methods and efficient work processes, managing lab workflow, personnel, and deliverables in a cGMP analytical chemistry laboratory responsible for testing OTC drug raw materials and finished products, pharmaceuticals, and other products by LC-MS and GC-MS methods.

Responsibilities:

• Build and manage MS lab, workflow, personnel, and deliverables in a cGMP-compliant analytical laboratory responsible for using LC-MS and GC-MS for testing OTC drug, dietary supplement, cosmetic, and Rx Pharma products.
• Establish MS Lab best practices, SOPs, work processes, workflow, and reporting templates.
• Develop and validate both 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 our mass spectrometry, GC-MS, and LC-MS subject matter expert (SME).
• Train MS Lab Associate(s) in new methods, instrumentation, and standard operating procedures
• Oversee laboratory daily operations, people and processes to assure timely deliverables.
• Identify best vendors for equipment, reagents, and disposables to install and establish 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 quality data for testing results across multiple MS methods and platforms. Provide daily quality control data review of results coming from MS Lab.
• Represent the MS Lab in internal, client, and regulatory body audits.
• Hire, train, and manage MS Lab staff, including annual reviews.
• Lead troubleshooting of all MS Lab issues. Conduct investigations regarding out of specifications (OOS) results and address/manage deviations related to MS procedures.
• Maintain and troubleshoot GC-MS, LC-MS, and other MS Lab equipment.

You should have most of the following:

• PhD in Chemistry preferred, other Life Sciences acceptable, with 5+ years MS Lab experience with significant people and process responsibility. Experience in an FDA cGMP-regulated environment highly preferred. Or,
• MS with 10+ years experience will be considered with 5+ years experience managing people, developing and running methods for GC-MS and LC-MS instruments in an FDA cGMP-regulated environment.
• Experience maintaining and troubleshooting a broad array of analytical lab instruments with deep knowledge of single quadrupole, triple quadrupole, and advanced MS instruments interfaced with both LC and GC separation platforms.
• Knowledgeable and proficient 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 independent worker, program and platform builder, and problem solver.
• Proven ability to work in high stress, rapid growth environment.
• Excellent people, communication, and leadership skills.
• Able to prioritize routine tasks and adapt to a changing environment.