Senior Manager - Laboratory Operations, Stability & Critical Reagents

Senior Manager, Laboratory Operations, Stability & Critical Reagents

At Insmed, every moment and every patient counts and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress.

For patients, for each other, and for the future of science, we're in. Are you?

We're looking for a Senior Manager, Laboratory Operations, Stability & Critical Reagents within the Analytical Development & QC team to help us expand what's possible for patients with serious diseases. Reporting to the Senior Director, Large Molecule 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, instrument compliance, biologics reference standard and critical reagent programs to support GxP operations, regulatory requirements, and business objectives.

What You'll Do:

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 biologics reference standard and critical reagent management programs, including receipt, qualification, inventory control, storage, and disposal
• Serve as a point of contact for internal and external (CMO/CRO) laboratories related to stability programs including management of stability sample logistics, timelines and data deliverables.
• 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

Who You Are:

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

You are or you also have:

• 3+ years of experience managing laboratory operations, metrology, instrumentation, or laboratory support functions
• Demonstrated experience supporting analytical laboratories in GxP-regulated environments
• Experience with qualification, calibration, maintenance, and troubleshooting of analytical instrumentation, including HPLC, UPLC, Capillary Electrophoresis, GC, dissolution systems, balances, spectroscopic instruments, and environmental monitoring systems
• Experience in managing biologics reference standard programs and critical reagents
• Experience in managing stability programs

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

Where You'll Work

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.

Travel Requirements

Minimal travel expected

#LI-ONSITE

#LI-MC1

Pay Range:

$127,000.00-165,500.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our missionintentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

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.