Senior Manager - Laboratory Operations
Insmed Incorporated
August 20, 2026
On-site
Bridgewater, NJ
Operations
Manager, Laboratory Operations (Analytical Development)
What You’ll Do
- Lead and manage laboratory metrology and instrumentation programs, including calibration, qualification, maintenance, computer system validation (CSV), and lifecycle management of analytical equipment.
- Ensure timely execution and documentation of instrument calibrations, qualifications, maintenance, and repairs.
- Serve as primary point of contact for equipment vendors, service providers, and calibration contractors.
- Manage service agreements and support procurement for laboratory instruments, consumables, and metrology services.
- Support instrument selection, installation, commissioning, IQ/OQ/PQ, and implementation of new technologies.
- Oversee laboratory computerized systems and support CSV for instrumentation and software qualification.
- Write, review, and approve metrology-related documentation (SOPs, protocols, reports, change controls, deviations, CAPAs, risk assessments).
- Lead investigations for equipment failures, calibration excursions, and instrument performance issues.
- Establish/maintain reference standard and critical reagent programs (receipt, qualification, inventory control, storage, disposal).
- Ensure inspection readiness; support internal audits, customer audits, and regulatory inspections.
- Develop and monitor laboratory operational metrics, KPIs, and continuous improvement initiatives.
Who You Are
- Bachelor’s degree and 5+ years of experience in pharmaceutical/biotechnology or related regulatory environments.
You Are Or Also Have
- 3+ years managing laboratory operations, metrology, instrumentation, or lab support functions.
- Experience supporting analytical laboratories in cGMP-regulated environments.
- Experience qualifying, calibrating, maintaining, and troubleshooting analytical instrumentation (HPLC/UHPLC/GC/dissolution systems, balances, spectroscopic instruments, environmental monitoring).
Nice to Have
- Advanced degree in a related scientific discipline.
- Experience with computerized laboratory systems and CSV.
- Experience managing reference standard programs and laboratory asset management systems.
Where You’ll Work
- Bridgewater, NJ office; full-time, in-person.
Travel Requirements
- Minimal travel.
Pay Range
- $127,000.00–165,500.00 annual.
Application Instructions
- Current employees: apply via Jobs Hub in Workday.
- Applications accepted for 5 calendar days from date posted or until position is filled.
What You’ll Do
- Lead and manage laboratory metrology and instrumentation programs, including calibration, qualification, maintenance, computer system validation (CSV), and lifecycle management of analytical equipment.
- Ensure timely execution and documentation of instrument calibrations, qualifications, maintenance, and repairs.
- Serve as primary point of contact for equipment vendors, service providers, and calibration contractors.
- Manage service agreements and support procurement for laboratory instruments, consumables, and metrology services.
- Support instrument selection, installation, commissioning, IQ/OQ/PQ, and implementation of new technologies.
- Oversee laboratory computerized systems and support CSV for instrumentation and software qualification.
- Write, review, and approve metrology-related documentation (SOPs, protocols, reports, change controls, deviations, CAPAs, risk assessments).
- Lead investigations for equipment failures, calibration excursions, and instrument performance issues.
- Establish/maintain reference standard and critical reagent programs (receipt, qualification, inventory control, storage, disposal).
- Ensure inspection readiness; support internal audits, customer audits, and regulatory inspections.
- Develop and monitor laboratory operational metrics, KPIs, and continuous improvement initiatives.
Who You Are
- Bachelor’s degree and 5+ years of experience in pharmaceutical/biotechnology or related regulatory environments.
You Are Or Also Have
- 3+ years managing laboratory operations, metrology, instrumentation, or lab support functions.
- Experience supporting analytical laboratories in cGMP-regulated environments.
- Experience qualifying, calibrating, maintaining, and troubleshooting analytical instrumentation (HPLC/UHPLC/GC/dissolution systems, balances, spectroscopic instruments, environmental monitoring).
Nice to Have
- Advanced degree in a related scientific discipline.
- Experience with computerized laboratory systems and CSV.
- Experience managing reference standard programs and laboratory asset management systems.
Where You’ll Work
- Bridgewater, NJ office; full-time, in-person.
Travel Requirements
- Minimal travel.
Pay Range
- $127,000.00–165,500.00 annual.
Application Instructions
- Current employees: apply via Jobs Hub in Workday.
- Applications accepted for 5 calendar days from date posted or until position is filled.