Senior Analytical Chemistry Manager

3 weeks ago

South Plainfield, New Jersey, United States Medix™ Full time
Job Summary

Medix™ is seeking a highly skilled and experienced Senior Analytical Chemistry Manager to lead our Mass Spectrometry Laboratory. As a key member of our team, you will be responsible for overseeing the day-to-day operations of the lab, ensuring the production of high-quality data, and maintaining a cGMP-compliant environment.

Key Responsibilities
  • Lab Operations
    • Oversee the setup and day-to-day operations of the Mass Spectrometry Laboratory, including managing workflows, personnel, and deliverables for LC-MS and GC-MS analyses.
    • Develop and implement laboratory best practices, standard operating procedures (SOPs), work processes, and reporting templates to ensure compliance with regulatory requirements and quality standards.
  • Method Development and Validation
    • Create and validate mass spectrometry and chromatography parameters and methods for the quantitation of analytes using LC-MS and GC-MS.
    • Write, review, and update SOPs and oversee method development and validation to ensure accuracy and reliability of results.
  • Expertise and Training
    • Act as the go-to expert for Mass Spectrometry, GC-MS, and LC-MS technologies, providing guidance and expertise in these areas.
    • Train laboratory staff on new methods, instruments, and SOPs to ensure a high level of competence and proficiency.
  • Quality Control and Assurance
    • Conduct daily quality control reviews of laboratory results to ensure accuracy and reliability.
    • Represent the laboratory during internal, client, and regulatory body audits, addressing any issues related to laboratory procedures and results.
  • Staff Management
    • Recruit, train, and manage laboratory staff, including conducting annual performance reviews and leading troubleshooting efforts for laboratory issues.
Requirements
  • Education and Experience
    • PhD in Chemistry or a related Life Sciences field preferred, with 5+ years of Mass Spectrometry laboratory experience, including significant management responsibilities.
    • Experience in an FDA cGMP-regulated environment is highly preferred. Alternatively, an MS degree with 10+ years of experience, including 5+ years in a management role within a cGMP-regulated setting, will be considered.
  • Technical Expertise
    • Extensive experience with maintaining and troubleshooting a range of analytical laboratory instruments, including single quadrupole, triple quadrupole, and advanced MS systems interfaced with LC and GC platforms.
    • Proficient in a variety of analytical services such as quantitation, potency testing, residual solvents, extractables & leachables, nitrosamines, pesticides, bioanalytical studies, pharmacokinetics, and metabolism studies.
  • Skills
    • Demonstrated ability to work independently, build programs and platforms, and solve complex problems.
    • Proven track record of functioning well under high-stress conditions in a rapidly growing environment.
    • Excellent interpersonal, communication, and leadership skills.
    • Ability to prioritize tasks and adapt to a dynamic work environment.

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