Manager - Laboratory Operations

About The Role

We’re looking for a Manager, Laboratory Operations on the Analytical Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Director, Analytical Development & QC you’ll lead and manage laboratory metrology and instrumentation programs to ensure reliable operation, calibration, qualification, maintenance, computer system validation (CSV) and lifecycle management of analytical equipment. You will oversee calibration and metrology activities, laboratory asset management, reference standard programs, and instrument compliance to support cGMP operations, regulatory requirements, and business objectives.

Responsibilities

In this role, you’ll have the opportunity to manage laboratory personnel and collaborate closely with Analytical Development, Quality Control, Quality Assurance, Engineering, IT, and external vendors to ensure operational excellence, inspection readiness, and continuous improvement of laboratory systems and processes. You’ll also:

• Ensure timely execution and documentation of instrument calibrations, qualifications, maintenance, and repairs
• Serve as the primary point of contact for equipment vendors, service providers, and calibration contractors
• Manage service agreements and support procurement activities for laboratory instruments, consumables, and metrology services
• Support instrument selection, installation, commissioning, IQ/OQ/PQ activities, and implementation of new technologies
• Oversee laboratory computerized systems and support Computer System Validation (CSV) activities for laboratory instrumentation and software qualification
• Write, review and approve metrology-related documentation, including SOPs, protocols, reports, change controls, deviations, CAPAs, and risk assessments
• Lead investigations related to equipment failures, calibration excursions, and instrument performance issues
• Establish and maintain reference standard and critical reagent management programs, including receipt, qualification, inventory control, storage, and disposal
• Ensure laboratory equipment and systems remain inspection-ready and support internal audits, customer audits, and regulatory inspections
• Develop and monitor laboratory operational metrics, KPIs, and continuous improvement initiatives

Requirements

You have a Bachelor’s degree along with 5+ years of experience in pharmaceutical, biotechnology or related regulatory industry environments.

• 3+ years of experience managing laboratory operations, metrology, instrumentation, or laboratory support functions
• Demonstrated experience supporting analytical laboratories in cGMP-regulated environments
• Experience with qualification, calibration, maintenance, and troubleshooting of analytical instrumentation, including HPLC, UHPLC, GC, dissolution systems, balances, spectroscopic instruments, and environmental monitoring systems

Qualifications

Nice To Have (but Not Required):

• Advanced degree in Chemistry, Pharmaceutical Sciences, Engineering, Biology, or a related scientific discipline
• Experience with computerized laboratory systems and Computer System Validation (CSV) activities
• Experience managing reference standard programs and laboratory asset management systems

Schedule

This role is based out of our Bridgewater, NJ office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

Minimal travel expected.

Pay

$127,000.00 - $165,500.00 Annual

Benefits

Highlights Of Our U.S. Offerings Include:

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.