Specialist Manufacturing New Product Introduction (NPI): Downstream Readiness (Biotechnology)

Location: Holly Springs, North Carolina, United States

Annual base salary: USD 107,545.40–145,502.60

Company

Biotechnology company developing treatments and operating an advanced biologics drug substance manufacturing facility with disposable and stainless-steel technologies, Industry 4.0 capabilities, and sustainability initiatives.

What you will do

• Lead New Product Introduction activities for new drug substance products and advanced technologies.
• Coordinate Manufacturing, Process Development, Supply Chain, Planning, Facilities, Engineering, Quality, and other stakeholders using project management tools.
• Host cross-functional meetings and drive technology-transfer timelines into the manufacturing facility.
• Maintain accurate production documents and support 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, operational excellence, and plant-level continuous improvement initiatives.

Requirements

• Biologics drug substance manufacturing background with strong cross-functional project management and communication skills.
• High school diploma/GED with 10 years of biotechnology operations experience, or an associate’s degree with 8 years, bachelor’s degree with 4 years, master’s degree in chemistry, biology, or engineering with 2 years, or a doctorate degree.
• Experience in GMP manufacturing operations and technical knowledge of drug substance processing in cell culture or purification.
• Knowledge of chromatography, filtration, buffer compounding, and related bioprocessing disciplines.
• Ability to analyze technical data through trend analysis, forecasting, and modeling, and communicate complex information in presentations and technical writing.
• Ability to coach, mentor, or cross-train colleagues in core technical areas.

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 biannual company-wide shutdowns.
• Flexible work models, including remote arrangements where applicable.
• Career development opportunities and support for professional and personal well-being.