Specialist Manufacturing New Product Introduction (NPI): Upstream Readiness

Location: Holly Springs, North Carolina, United States

Company

hirify.global is developing and operating an advanced biologics drug substance manufacturing facility using disposable technologies, stainless-steel equipment, industry 4.0 capabilities, and sustainability initiatives.

What you will do

• Lead New Product Introduction projects for biologics drug substance products and advanced technologies.
• Coordinate Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, Quality, and other stakeholders.
• Host cross-functional meetings and drive timelines for technology transfer into the manufacturing facility.
• Maintain accurate production documentation and support troubleshooting, problem-solving, root-cause analyses, and CAPA development.
• Own NPI change controls, support regulatory questions and audit findings, and drive on-time completion.
• Lead lean transformation and operational excellence initiatives while tracking plant-level progress.

Requirements

• High school diploma/GED with 10 years of biotechnology operations experience, or an associate degree with 8 years, or a bachelor's degree with 4 years, or a master's degree in chemistry, biology, or engineering with 2 years, or a doctorate degree.
• Background in biologics drug substance manufacturing and GMP manufacturing operations.
• Strong cross-functional project management, meeting facilitation, technical writing, and communication skills.
• Technical knowledge of drug substance processing in cell culture or purification, including chromatography, filtration, and buffer compounding.
• Ability to analyze technical data through trend analysis, forecasting, and modeling, and to communicate complex information to varied audiences.
• Experience coaching, mentoring, or cross-training colleagues, with knowledge of lean manufacturing and operational excellence.

Culture & Benefits

• Full-time employment with health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions and stock-based long-term incentives.
• Discretionary annual bonus program.
• Paid time-off plans and bi-annual company-wide shutdowns.
• Flexible work models, including remote arrangements where possible.
• Career development opportunities and support for professional and personal well-being.