Senior Manager – Manufacturing Programs - Process Owner Organization

Location: Holly Springs, North Carolina, United States; onsite manufacturing role

Salary: USD 154,173–208,587 per year

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines, including products produced at its advanced FleX batch drug substance manufacturing facility.

What you will do

• Lead and develop the Process Owner organization supporting upstream, downstream, and services drug substance unit operations.
• Provide technical process stewardship, manufacturing floor support, hypercare, operational readiness, and process governance.
• Build a swing-shift Process Owner team to expand manufacturing coverage.
• Coordinate dry runs, water runs, engineering runs, startup activities, and first-time manufacturing executions.
• Lead manufacturing change controls, CAPAs, SOP governance, GMP documentation, and BOM management.
• Partner with Quality, Engineering, Process Development, C&Q, Supply Chain, and Digital Manufacturing on process implementation and continuous improvement.

Requirements

• Doctorate plus 2 years, master’s degree plus 6 years, bachelor’s degree plus 8 years, associate’s degree plus 10 years, or high school diploma/GED plus 12 years of biotechnology or pharmaceutical industry experience.
• At least 2 years of direct people management or leadership experience leading teams, projects, programs, or resource allocation.
• Experience in biotechnology or pharmaceutical manufacturing with progressively increasing responsibility.
• Strong understanding of GMP manufacturing operations and experience with process ownership, technical process stewardship, and manufacturing support.
• Experience with electronic batch records, manufacturing execution systems, digital manufacturing implementation, GMP documentation, CAPAs, and change controls.
• Strong organizational, written, verbal communication, and cross-functional leadership skills.

Culture & Benefits

• Work within a newly developed, advanced drug substance manufacturing facility.
• Manufacturing environment combining single-use technologies, stainless steel equipment, and industry 4.0 capabilities.
• Focus on safety, quality, compliance, accountability, collaboration, operational excellence, and continuous improvement.
• Support sustainability initiatives intended to reduce carbon emissions and waste.