Specialist Manufacturing New Product Introduction (NPI): Downstream Readiness

Location: Holly Springs, North Carolina, United States

Company

hirify.global is a biotechnology company developing and manufacturing biologic medicines, including products produced at its advanced FleXBatch drug substance manufacturing facility.

What you will do

• Coordinate New Product Introduction programs for new drug substance products and advanced technologies.
• Lead cross-functional collaboration across Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, and Quality.
• Ensure production documents are accurate and up to date and support technical projects.
• Support manufacturing troubleshooting, problem-solving, root-cause analyses, and CAPA development.
• Own NPI change controls, drive on-time completion, and respond to regulatory questions and audit findings.
• Champion lean transformation and operational excellence initiatives while tracking plant-level progress.

Requirements

• High school diploma/GED and 10 years of biotechnology operations experience, or an associate degree and 8 years, or a bachelor's degree and 4 years, or a master's degree in chemistry, biology, or engineering and 2 years, or a doctorate degree.
• Background in biologics drug substance manufacturing and GMP manufacturing operations.
• Strong cross-functional project management, meeting facilitation, communication, and technical writing skills.
• Technical knowledge of cell culture or purification, including chromatography, filtration, and buffer compounding.
• Ability to analyze technical data through trend analysis, forecasting, and modeling.
• Ability to coach, mentor, or cross-train colleagues in core technical areas.

Culture & Benefits

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