Front Line Manufacturing Manager (Biologics)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Location: Holly Springs, North Carolina, United States. The role begins with a Monday–Friday, 8:00 a.m.–5:00 p.m. startup schedule and transitions to a 12-hour 2-2-3 day-shift schedule from 5:45 a.m. to 6:15 p.m. supporting 24/7 manufacturing operations. Nonstandard hours, holidays, inclement-weather shifts, and overtime may be required.
Company
is a biotechnology company developing treatments and operating an advanced drug substance manufacturing facility with disposable and stainless-steel technologies.
What you will do
- Lead, develop, and coach a downstream manufacturing team while establishing expectations for safety, quality, and accountability.
- Support the design, build, commissioning, qualification, staffing, training, and operational readiness of a new manufacturing facility.
- Oversee cGMP-compliant downstream purification operations, including column packing, chromatography, TFF, viral filtration, viral inactivation, conjugation, and final fill.
- Support technology transfer and process implementation, including manufacturability, troubleshooting, and continuous improvement.
- Partner with Quality, Engineering, NPI, Supply Chain, Validation, and site leadership during startup and manufacturing ramp-up.
- Maintain inspection readiness and drive improvements in operational efficiency, reliability, and scalability.
Requirements
- Doctorate; or a master’s degree with 3 years of manufacturing or operations experience; or a bachelor’s degree with 5 years; or an associate degree with 10 years; or a high school diploma/GED with 12 years.
- Previous managerial experience directly managing people or experience leading teams, projects, programs, or resource allocation.
- Ability to work assigned 12-hour shifts, including nonstandard hours, some holidays, inclement weather, and requested overtime.
- Experience with manufacturing operations, safety and quality standards, and regulatory requirements.
- Preferred experience with facility startup, commissioning, operational readiness, biologics or downstream drug substance manufacturing, cGMP, technology transfer, and process implementation.
- Proficiency with MES/EBR, DeltaV, Maximo, Veeva, LIMS, and electronic quality systems is preferred.
Culture & Benefits
- Health, dental, vision, life, disability, and flexible spending benefits for employees and eligible dependents.
- Retirement and savings plan with company contributions.
- Discretionary annual bonus program and stock-based long-term incentives.
- Paid time-off plans and biannual company-wide shutdowns.
- Career development opportunities and flexible work models where applicable.
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