Senior Manager: Manufacturing - Downstream Bulk Drug Substance (Biotechnology Manufacturing)

Location: Holly Springs, North Carolina, United States

Salary: $136,227.80–$184,308.20 per year

Company

hirify.global is a biotechnology company developing treatments and operating advanced drug substance manufacturing facilities.

What you will do

• Lead the team responsible for 24/7 downstream purification manufacturing operations.
• Support commissioning, qualification, start-up, and GMP operation of a new drug substance manufacturing facility.
• Design the manufacturing organization and oversee workforce planning, hiring, onboarding, training, qualification, and development.
• Provide manufacturing leadership for design reviews, system walkdowns, acceptance testing, equipment qualification, process demonstrations, and equipment turnover.
• Lead downstream chromatography column packing activities, including planning, qualification, troubleshooting, documentation, and readiness.
• Drive operational readiness, regulatory inspection preparation, deviation investigations, corrective actions, and continuous improvement.

Requirements

• Doctorate degree and 2 years of Manufacturing & Operations experience, or a Master’s degree and 6 years, Bachelor’s degree and 8 years, Associate’s degree and 10 years, or High School diploma/GED and 12 years.
• At least 2 years of managerial experience directly managing people, leading teams or projects, or directing resource allocation.
• Experience developing and coaching staff and building strong cross-functional relationships.
• Ability to collaborate with Quality, Process Development, Engineering, Supply Chain, Automation, Validation, and project teams.
• Ability to support safe, compliant, reliable, and inspection-ready GMP manufacturing operations.

Nice to have

• Managerial experience in a GMP drug substance manufacturing plant.
• Experience applying Operational Excellence and Lean Manufacturing.
• Cross-functional experience in Process Development, Quality, or Engineering.
• Strong communication, problem-solving, urgency, and relationship-building skills.

Culture & Benefits

• Opportunities to learn and advance across a global organization.
• Diverse and inclusive community that empowers employees to contribute ideas and act.
• Total Rewards Plan covering health, finance and wealth, work-life balance, and career benefits.
• Work in a new FleX Batch facility combining single-use technologies, stainless-steel equipment, Industry 4.0 capabilities, and sustainability initiatives.