Front Line Manufacturing Manager (Bulk Drug Substance Services)

Location: Holly Springs, North Carolina, United States. The role is facility-based and requires regular attendance, including Monday–Friday startup hours followed by a 12-hour 2-2-3 day-shift schedule.

Company

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

What you will do

• Lead, develop, and coach the manufacturing team while promoting safety, quality, accountability, and performance.
• Support the design, build, commissioning, qualification, staffing, training, and operational readiness of the new facility.
• Oversee safe, cGMP-compliant manufacturing operations across logistics, weighing and dispensing, solution preparation, parts washing, autoclaving, and material handling.
• Support technology transfer, process implementation, manufacturability, troubleshooting, and continuous improvement.
• Partner with Quality, Engineering, NPI, Supply Chain, Validation, and site leadership during startup and ramp-up.
• Maintain inspection readiness and support nonstandard hours, overtime, holidays, and 24/7 operations as required.

Requirements

• Doctorate; or a master’s degree with 3 years of manufacturing or operations experience; or a bachelor’s degree with 5 years; or an associate degree with 10 years; or a high school diploma/GED with 12 years.
• Previous managerial experience directly managing people, or experience leading teams, projects, programs, or resource allocation.
• Experience with manufacturing operations and the ability to work assigned 12-hour shifts, including during inclement weather and holidays when required.
• Experience with cGMP manufacturing, regulatory requirements, and operational issue resolution.
• Ability to collaborate across Quality, Engineering, NPI, Supply Chain, Validation, and site leadership.
• Must work onsite in Holly Springs, North Carolina, and support changing schedules for startup and 24/7 manufacturing operations.

Nice to have

• Bachelor’s degree in Life Sciences or Engineering.
• Facility startup, commissioning, or operational readiness experience.
• Biologics or drug substance manufacturing experience and 5+ years of cGMP manufacturing experience.
• Technology transfer and process implementation experience.
• Experience with MES/EBR, DeltaV, Maximo, Veeva, LIMS, and electronic quality systems.

Culture & Benefits

• 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.
• Paid time off and biannual company-wide shutdowns.
• Career development opportunities and flexible work models where applicable.