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Job Title: Mass Spectrometry Lab Manager

Reports To: Lab Director

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:

• Education: PhD in Chemistry preferred; other Life Sciences considered.

• 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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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About Kelly

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Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.