7 дней назад
Senior Manager, Laboratory Operations (Analytical Development)
127 000 - 165 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager, Laboratory Operations (Analytical Development): Leading laboratory metrology and instrumentation programs for analytical development and cGMP operations with an accent on calibration, qualification, maintenance, computer system validation, and equipment lifecycle management. Focus on ensuring inspection readiness, investigating equipment failures, managing reference standards, and driving continuous improvement across laboratory systems.
Location: Bridgewater, New Jersey, United States; full-time, in-person presence required
Salary: $127,000–$165,500 annual
Company
is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.
What you will do
- Lead laboratory metrology and analytical instrumentation programs covering calibration, qualification, maintenance, repairs, and 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, and implementation of new technologies.
- Oversee laboratory computerized systems and Computer System Validation activities.
- Write, review, and approve SOPs, protocols, reports, change controls, deviations, CAPAs, and risk assessments.
- Lead equipment investigations, maintain inspection readiness, manage reference standards, and monitor laboratory KPIs and improvement initiatives.
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 cGMP-regulated environments.
- Experience with qualification, calibration, maintenance, and troubleshooting of HPLC, UHPLC, GC, dissolution systems, balances, spectroscopic instruments, and environmental monitoring systems.
- Ability to work full-time in person at the Bridgewater, NJ office.
Nice to have
- Advanced degree in Chemistry, Pharmaceutical Sciences, Engineering, Biology, or a related scientific discipline.
- Experience with computerized laboratory systems and CSV activities.
- Experience managing reference standard programs and laboratory asset management systems.
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 work schedules with purposeful in-person collaboration.
- 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
- Learning programs, LinkedIn Learning, workshops, leadership development, mentorship, and networking opportunities.
- Employee resource groups, service programs, recognition programs, and volunteer opportunities.
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