11 дней назад
Manufacturing Programs Senior Manager: New Product Introduction (NPI) (Biotechnology)
154 173 - 208 587$
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Описание вакансии
Текст:
TL;DR
Manufacturing Programs Senior Manager: New Product Introduction (NPI) (Biotechnology): Coordinating the introduction of new biologics drug substance products and advanced technologies into a manufacturing facility with an accent on cross-functional project management, technical troubleshooting, and GMP production documentation. Focus on leading NPI specialists, supporting root-cause analysis and CAPA development, and driving lean transformation and operational excellence initiatives.
Location: Holly Springs, North Carolina, United States
Annual base salary: $154,173–$208,587
Company
is a biotechnology company developing treatments and operating advanced biologics drug substance manufacturing facilities.
What you will do
- Coordinate new product introductions and technology transfers into the biologics manufacturing facility.
- Interface with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, Quality, and other cross-functional groups.
- Lead NPI manufacturing specialists and build a supportive, high-performing team culture.
- Resolve technical challenges, troubleshoot manufacturing issues, and support root-cause analyses and CAPA development.
- Ensure production documents are accurate and current.
- Champion lean transformation and operational excellence initiatives while tracking plant-level progress.
Requirements
- Biologics drug substance manufacturing background with strong project management and communication skills.
- Doctorate plus 2 years of biotechnology operations experience; or master’s degree plus 6 years; bachelor’s degree plus 8 years; associate’s degree plus 10 years; or high school diploma/GED plus 12 years.
- At least 2 years of direct people management or leadership experience leading teams, projects, programs, or resource allocation.
- Experience in GMP manufacturing operations and knowledge of drug substance processing in cell culture or purification.
- Ability to analyze technical data through trend analysis, forecasting, or modeling and communicate complex information in presentations and technical writing.
- Experience with coaching, mentoring, lean manufacturing, or operational excellence.
Nice to have
- Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry.
- Experience with chromatography, filtration, or buffer compounding.
- Strong meeting facilitation and technical writing skills.
Culture & Benefits
- Full-time employment with health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Discretionary annual bonus and stock-based long-term incentives.
- Time-off plans and bi-annual company-wide shutdowns.
- Flexible work models, including remote arrangements where possible.
- Career development and work-life balance support.
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