2 дня назад
Senior Manager - Laboratory Operations, Stability & Critical Reagents
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager - Laboratory Operations, Stability & Critical Reagents (Biopharmaceutical Laboratory Operations): Managing laboratory personnel, analytical instrumentation, stability programs, and critical reagent systems with an accent on GxP compliance, inspection readiness, and operational excellence. Focus on qualifying and maintaining laboratory equipment, leading investigations and CSV activities, and coordinating stability sample logistics and data deliverables.
Location: Bridgewater, New Jersey, United States; full-time, in-person presence required
Company
is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.
What you will do
- Manage laboratory operations, personnel, equipment, systems, and operational metrics.
- Oversee instrument calibration, qualification, maintenance, repairs, installation, commissioning, and IQ/OQ/PQ activities.
- Manage equipment vendors, service providers, service agreements, procurement, and laboratory technology implementation.
- Lead metrology documentation, investigations, deviations, CAPAs, risk assessments, and continuous improvement initiatives.
- Establish and maintain biologics reference standard and critical reagent programs, including qualification, inventory, storage, and disposal.
- Coordinate stability programs with internal and external laboratories, including sample logistics, timelines, and data deliverables.
Requirements
- Bachelor’s degree and 5+ years of experience in pharmaceutical, biotechnology, or related regulated industry environments.
- 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 programs, critical reagents, 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, vision, and mental health coverage.
- Paid time off, fertility and family-forming benefits, caregiver support, and wellbeing reimbursement.
- 401(k) plan with company match, annual equity awards, employee stock purchase plan, and company-paid life and disability insurance.
- Access to learning programs, LinkedIn Learning, workshops, leadership development, mentorship, and networking.
- Employee resource groups, service programs, recognition programs, and opportunities to volunteer.
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