Chemistry Operations Manager - FDA Detention

Overview

Chemistry Operations Manager - FDA Detention at Mérieux Nutri Sciences - North America. The Operations Manager – FDA Detention Testing leads a multidisciplinary chemistry team, ensures operational excellence in laboratory activities, and focuses on regulatory compliance, accuracy, and timely execution. The role serves as the key liaison to clients, FDA import officers, and internal stakeholders to meet high standards of quality and reliability.

• Provide overall leadership and operational management of analytical chemistry testing for FDA-detained imports.
• Ensure strict compliance with FDA regulatory requirements, GLP, ISO/IEC 17025, and other relevant industry standards.
• Oversee laboratory workflows including sample receipt, testing, data analysis, quality review, reporting, and client communication.
• Lead the development, validation, and implementation of robust analytical methods across diverse product categories (e.g., food, dietary supplements, spices).
• Supervise, mentor, and train laboratory staff to ensure technical excellence, regulatory awareness, and professional growth.
• Review, interpret, and approve analytical results, Certificates of Analysis (COAs), and QA/QC documentation to ensure accuracy and integrity.
• Serve as the primary liaison with FDA import officers, clients, and internal teams, ensuring transparency in testing scope, timelines, and deliverables.
• Prepare for and lead internal audits while ensuring readiness for external inspections by regulatory authorities.
• Drive continuous improvement initiatives, optimizing laboratory workflows, data integrity systems, and cost efficiency without compromising compliance.
• Oversee departmental P&L, ensuring financial accountability and sustainable business performance.
• Represent the company in client meetings, regulatory discussions, and industry forums with professionalism and scientific credibility.
• Ensure all operations are conducted in alignment with ethical standards and the company’s Code of Conduct.
• Other related duties as assigned.
• At all times, behave and operate in an ethical and Code of Conduct compliant manner.

• Bachelor’s degree in Chemistry, Analytical Chemistry, or a related scientific discipline.
• Minimum of 5 years of experience in an analytical chemistry or regulatory testing laboratory.
• At least 3 years of proven supervisory or managerial experience in a laboratory environment.
• Demonstrated success in managing laboratory budgets, including cost control for reagents, instrumentation, and staffing.
• Strong knowledge of Good Laboratory Practices (GLP), ISO standards (ISO/IEC 17025 preferred), and regulatory testing environments.

• Advanced degree (Master’s or PhD) in Chemistry, Analytical Chemistry, Food Science, or a related field.
• Direct experience with FDA import detention testing protocols and regulatory compliance.
• Proficiency in advanced analytical instrumentation (HPLC, GC, LC-MS/MS, ICP-MS, wet chemistry methods).
• Demonstrated project management expertise and business acumen with a track record of delivering results on time and within scope.
• Strong leadership, strategic thinking, and problem-solving skills, with the ability to influence across departments.
• Excellent verbal and written communication skills, with experience representing laboratory services to clients and regulatory authorities.

• Occasional travel may be required to attend industry conferences or collaborate with other research facilities.
• Typically involves travel within the country and lasts for short durations (1-3 days).

• Compensation Range: $85,000-$95,000 annual salary USD
• Potential bonus:
  Up to 10% based on performance.
• Comprehensive medical, dental, and vision insurance plans.
• Generous paid time off (PTO) package to support work-life balance following state and local ordinances.
• Optional 401(k) plan with employer matching contributions.

The information above provides a general overview and may vary based on specific job responsibilities, location, or other factors. Details will be clarified during the hiring process.

• Contribute to an inspiring Public Health purpose, supported by long-term and visionary shareholders.
• Impact our strategic pillars built on 50 years of experience and expertise.
• Be part of a diverse and open-minded environment in a collaborative, purpose-driven team.
• Grow in an international group of more than 8,200 team members with opportunities to learn and share.

To apply please click on the Apply now button.

• Mid-Senior level

• Full-time

• Management and Manufacturing