Mass Spectrometry Manager

Job Description

Job Description

Mass Spectrometry Lab Manager

Greater New York City

Position Overview

We are seeking a results-driven Mass Spectrometry (MS) Lab Manager who will lead our cGMP analytical chemistry laboratory to achieve excellence in testing OTC drug raw materials, finished products, pharmaceuticals, and more through LC-MS and GC-MS methods.

The ideal candidate will thrive in a "Builder" role, establishing best practices, standard operating procedures (SOPs), and efficient workflows, while developing and leading a high-performing team.

Key Performance Outcomes

The successful candidate will be accountable for the following performance outcomes :

1. Lab Establishment and Management : Build and manage a state-of-the-art MS lab, ensuring workflows, personnel, and deliverables align with cGMP compliance and industry standards.

2. Best Practices Development : Establish and implement SOPs and work processes that drive efficiency and quality in laboratory operations.

3. Analytical Method Development : Develop and validate robust LC-MS and GC-MS methods for quantitation of target analytes, ensuring high-quality and reproducible results.

4. Team Leadership and Training : Lead, train, and mentor MS Lab Associates, fostering a culture of continuous improvement and professional growth.

5. Vendor and Equipment Management : Identify and manage relationships with top vendors for equipment and reagents, optimizing lab capabilities.

6. Quality Assurance and Control : Ensure timely and accurate data generation, overseeing quality control processes and representing the lab during internal and regulatory audits.

7. Operational Excellence : Lead troubleshooting efforts for lab issues, managing deviations and investigations related to out-of-specification results.

Collaboration

You will report to the Lab Director and collaborate closely with the Lab Manager and QA Supervisor to achieve shared goals.

Candidate Profile

To excel in this role, candidates must demonstrate :

Expertise in cGMP Compliance : Proven experience in method validation and operational excellence within a FDA cGMP-regulated environment.

Mass Spectrometry Leadership : Extensive technical experience with LC-MS and GC-MS methodologies, serving as a subject matter expert (SME).

Team and Process Development : A history of building and leading teams while establishing efficient lab processes and practices.

Analytical Instrumentation Mastery : Deep knowledge of maintaining and troubleshooting a variety of MS instruments, including single quadrupole and triple quadrupole systems.

Diverse Analytical Skills : Proficiency in analytical services such as potency testing, residual solvents analysis, bioanalytical studies and extractables and leachables methods. (very important)

Adaptability and Problem-Solving : Ability to thrive in a fast-paced environment, prioritizing tasks and adapting to changing circumstances effectively.

Education and Experience

Education : PhD in Chemistry or related Life Sciences preferred, or MS with 10+ years of relevant experience.

Experience : Minimum of 5 years in an MS lab with significant people and process management responsibilities.

Interview Questions for Candidates

1. Can you detail your experience with method validation and compliance in a FDA cGMP environment?

2. What specific expertise do you bring as a Mass Spectrometry subject matter expert?

3. Have you worked in a testing lab business rather than Big Pharma? Please elaborate.

4. Describe your experience managing people and processes in a laboratory setting.

5. How have you ensured compliance in an FDA cGMP-regulated environment?

6. What is your experience with maintaining and troubleshooting a range of analytical lab instruments?

7. Do you meet the educational and experience requirements outlined in this description?

8. Please share your proficiency in a variety of analytical services, including quantitation and potency testing.

By focusing on performance and outcomes, we aim to find a candidate who can make a significant impact in our lab environment and drive our mission forward.