2 дня назад
Senior Manager, Laboratory Operations, Stability & Critical Reagents (Biotech)
127 000 - 165 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager, Laboratory Operations, Stability & Critical Reagents (Biotech): Leading laboratory metrology, analytical instrumentation, stability, biologics reference standard, and critical reagent programs in a GxP-regulated biopharmaceutical environment with an accent on equipment reliability, compliance, and inspection readiness. Focus on managing calibration and qualification activities, computerized system validation, equipment investigations, stability sample logistics, and continuous improvement of laboratory operations.
Location: Bridgewater, New Jersey, United States; full-time, in-person presence required
Salary: $127,000–$165,500 annual
Company
is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.
What you will do
- Lead laboratory metrology and analytical instrumentation programs covering calibration, qualification, maintenance, repairs, compliance, and equipment lifecycle management.
- Manage laboratory personnel and coordinate with Analytical Development, Quality Control, Quality Assurance, Engineering, IT, vendors, and service providers.
- Support instrument selection, installation, commissioning, IQ/OQ/PQ activities, new technology implementation, and computerized system validation.
- Write, review, and approve SOPs, protocols, reports, change controls, deviations, CAPAs, and risk assessments.
- Manage biologics reference standards and critical reagents, including qualification, inventory, storage, and disposal.
- Oversee stability programs with internal and external laboratories, including sample logistics, timelines, data deliverables, audits, inspections, KPIs, and continuous improvement.
Requirements
- Bachelor’s degree and 5+ years of experience in pharmaceutical, biotechnology, or related regulated industries.
- 3+ years of experience managing laboratory operations, metrology, instrumentation, or laboratory support functions.
- Experience supporting analytical laboratories in GxP-regulated environments.
- Experience with qualification, calibration, maintenance, and troubleshooting of HPLC, UPLC, capillary electrophoresis, GC, dissolution systems, balances, spectroscopic instruments, and environmental monitoring systems.
- Experience managing biologics reference standard, critical reagent, and stability programs.
- Ability to work full-time in person at the Bridgewater, New Jersey office.
Nice to have
- Advanced degree in Chemistry, Pharmaceutical Sciences, Engineering, Biology, or a related scientific discipline.
- Experience with computerized laboratory systems and Computer System Validation activities.
Culture & Benefits
- Medical, dental, and vision coverage, mental health support, wellbeing reimbursement, and an Employee Assistance Program.
- Paid time off, fertility and family-forming benefits, caregiver support, and flexible schedules with purposeful in-person collaboration.
- 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
- Learning resources, leadership programs, mentorship, networking, employee resource groups, and service programs.
- Minimal travel is expected.
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