3 дня назад
Manager Manufacturing (12hr PM)
106 148 - 143 612$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager Manufacturing (12hr PM) (Biotechnology): Managing a manufacturing production area or section of an Inspection and Packaging facility with an accent on cGMP compliance, production scheduling, staff development, and regulatory coordination. Focus on maintaining validated processes and equipment, resolving operational problems, coordinating SOP and change-control activities, and leading a rotating overnight 12-hour shift.
Location: New Albany, Ohio, United States; onsite manufacturing role supporting a rotating 12-hour overnight schedule from 6:00pm to 6:30am.
Expected annual salary: $106,148–$143,612 USD
Company
is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.
What you will do
- Manage and lead a small manufacturing production area or section of a larger Inspection and Packaging facility.
- Maintain production in full cGMP and CFR compliance, including reviewing reports, protocols, procedures, and SOPs.
- Coordinate change control, regulatory and quality communication, and interactions with the FDA.
- Oversee maintenance and revalidation of systems, critical process setup, and resolution of operational problems.
- Supervise, hire, train, evaluate, coach, and develop manufacturing staff while maintaining production and maintenance schedules.
- Support budgeting, department goals, plant safety audits, and organizational planning.
Requirements
- Doctorate degree; or a master's degree with 3 years of pharmaceutical, medical device, or biotechnology experience; or a bachelor's degree with 5 years of relevant experience; or an associate's degree with 10 years of relevant experience; or a high school diploma/GED with 12 years of relevant experience.
- Direct people-management experience or leadership experience leading teams, projects, programs, or resource allocation.
- Experience with regulatory requirements, production scheduling, analytical problem solving, and technical written and verbal communication.
- Availability to work a rotating overnight 12-hour schedule: 3 days one week and 4 days the next.
- Experience with non-conformance and CAPA, conflict resolution, coaching, mentoring, and managing change.
Culture & Benefits
- Collaborative, innovative, science-based work environment focused on serving patients.
- Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
- Retirement and savings plan with company contributions.
- Discretionary annual bonus program and stock-based long-term incentives.
- Paid time-off plans and career development opportunities.
- Sponsorship for this role is not guaranteed.
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