Senior Manager Manufacturing Programs- Process Owner Organization

Location: Holly Springs, North Carolina, United States

Company

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

What you will do

• Lead, develop, and provide career coaching for the Process Owner organization supporting upstream, downstream, and services drug substance unit operations.
• Establish a swing-shift Process Owner team to expand manufacturing floor coverage and hypercare support.
• Provide technical process stewardship and coordinate operational readiness, dry runs, water runs, engineering runs, startup activities, and first-time executions.
• Partner with Manufacturing Operations, Quality, Engineering, Process Development, C&Q, Supply Chain, and Digital Manufacturing.
• Lead manufacturing change controls, CAPAs, GMP documentation, SOP governance, BOM support, and inspection readiness.
• Support electronic batch record and MES implementation, translating manufacturing processes into digital workflows.

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 technical process stewardship.
• Experience with manufacturing support, process ownership, CAPAs, change controls, operational readiness, and GMP documentation.
• Strong organizational, written, verbal communication, and cross-functional leadership skills.

Nice to have

• Experience with electronic batch records, manufacturing execution systems, and digital manufacturing implementations.
• Experience with Veeva, Documentum, or similar quality systems.
• Experience supporting BOM management, material readiness, and manufacturing execution with Supply Chain teams.

Culture & Benefits

• Work in a newly developed drug substance manufacturing facility combining single-use technologies, stainless steel equipment, and industry 4.0 capabilities.
• Support a culture focused on safety, quality, compliance, accountability, collaboration, operational excellence, and continuous improvement.
• Contribute to sustainability initiatives designed to reduce carbon emissions and waste.