Manager Manufacturing, New Product Introduction - Downstream (Biotechnology)

Location: Holly Springs, North Carolina, United States

Salary range: USD - USD

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for patients worldwide.

What you will do

• Manage the New Product Introduction team responsible for introducing new products and advanced technologies into the GMP drug substance manufacturing plant.
• Hire, train, evaluate, mentor, and develop team members while driving performance and continuous improvement.
• Coordinate product introductions, process changes, improvements, and technology implementation with Process Development, Drug Substance Technologies & Engineering, Supply Chain, Facilities, Engineering, Quality, and Manufacturing.
• Lead team alignment, assess capability and resource needs, and support department goals and budget planning.
• Champion lean transformation and operational excellence initiatives across the plant.
• Maintain inspection readiness, oversee change control documentation, and support regulatory responses, audits, and agency interactions.

Requirements

• Doctorate degree; or a master's degree plus 3 years, bachelor's degree plus 5 years, associate's degree plus 10 years, or high school diploma/GED plus 12 years of biotechnology or pharmaceutical manufacturing experience.
• Direct people-management experience or leadership experience directing teams, projects, programs, or resource allocation.
• Experience with GMP operations and New Product Introduction in biotechnology or pharmaceutical manufacturing.
• Strong technical knowledge of drug substance processing, including cell culture, harvest, chromatography, filtration, and buffer compounding.
• Ability to analyze technical data, communicate complex information, and collaborate across functional and organizational levels.
• Experience with lean manufacturing, operational excellence, and cross-functional project management.

Nice to have

• Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry.
• Experience with PAS X or Werum software.
• Experience leading direct reports and coaching or cross-training colleagues.

Culture & Benefits

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