Front Line Manufacturing Manager - Bulk Drug Substance Services - Days (Biotechnology)

Location: Holly Springs, North Carolina, United States. The role starts with a Monday–Friday, 8:00 a.m.–5:00 p.m. schedule and transitions to a 12-hour 2-2-3 day shift from 5:45 a.m. to 6:15 p.m. Support outside standard hours, holidays, inclement weather, and overtime may be required.

Company

hirify.global is a biotechnology company developing patient treatments and operating a new drug substance manufacturing facility with disposable technologies, stainless-steel equipment, Industry 4.0 capabilities, and sustainability initiatives.

What you will do

• Lead, develop, and coach manufacturing teams across raw material and solution logistics, weighing and dispensing, buffer and media preparation, parts washing, autoclaving, and material handling.
• Support the design, build, commissioning, qualification, staffing, training, and operational readiness of the new facility.
• Ensure safe, cGMP-compliant manufacturing execution while managing safety, quality, schedule, cost, deviations, and operational issues.
• Support technology transfer, process implementation, troubleshooting, manufacturability, and continuous improvement.
• Collaborate with Quality, Engineering, NPI, Supply Chain, Validation, and site leadership during startup and ramp-up.
• Maintain inspection readiness and support the transition from facility startup to 24/7 manufacturing operations.

Requirements

• Doctorate degree, or a master’s degree with 3 years of manufacturing or operations experience.
• Bachelor’s degree with 5 years, associate’s degree with 10 years, or high school diploma/GED with 12 years of manufacturing or operations experience.
• Previous managerial experience managing people or leading teams, projects, programs, or resource allocation.
• Ability to work assigned 12-hour shifts and nonstandard hours in support of startup, commissioning, qualification, and 24/7 operations.
• Experience with cGMP manufacturing, regulatory requirements, and inspection readiness.
• Proficiency with MES/EBR, DeltaV, Maximo, Veeva, LIMS, and electronic quality systems.

Nice to have

• Bachelor’s degree in Life Sciences or Engineering.
• Facility startup, commissioning, or operational readiness experience.
• Biologics or drug substance manufacturing experience.
• Technology transfer and process implementation experience.
• Area Lead, Specialist, or Manager experience with strong performance management and conflict resolution skills.

Culture & Benefits

• Health, dental, vision, life, disability, and flexible spending benefits for employees and eligible dependents.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time-off plans and biannual company-wide shutdowns.
• Career development opportunities and flexible work models where applicable.