Senior Associate Manufacturing (Technical Training - Upstream Bulk Drug Substance)

Location: Holly Springs, North Carolina, United States. The role supports all four shifts covering 24/7 manufacturing operations.

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines, including products made at its advanced drug substance manufacturing facilities.

What you will do

• Support the development and execution of the manufacturing training strategy for cell culture, purification, and manufacturing services.
• Lead and organize manufacturing new-hire orientation and maintain relevant training content.
• Perform job task analyses on the manufacturing floor and create performance-support materials, including SOP updates, videos, and one-slide updates.
• Support complex investigations, change controls, quality initiatives, and operational Learning Team activities.
• Maintain annual requalification programs, Training Assignment Profiles, and Assignment Vehicles for manufacturing areas.
• Serve as the Learning Management System subject matter expert and present complex topics to manufacturing staff, management, and cross-functional partners.

Requirements

• Master’s degree; or bachelor’s degree plus 6 months of manufacturing or operations experience; or associate degree plus 2 years of manufacturing or operations experience; or high school diploma/GED plus 4 years of manufacturing or operations experience.
• Experience in biologics or pharmaceutical manufacturing, process development, or quality assurance; 5+ years of related experience is preferred.
• Experience developing and facilitating training, creating technical content, writing SOPs, and working with Learning Management Systems.
• Experience with aseptic techniques, laminar flow hood operation, and Quality Management Systems such as TrackWise or Veeva for deviation investigations and CAPAs.
• Strong project management, written and verbal communication, presentation, interpersonal, and cross-functional collaboration skills.
• Ability to support all four shifts covering 24/7 operations and work at the Holly Springs manufacturing site.

Nice to have

• Degree in science or engineering.
• Experience presenting to inspectors during regulatory inspections and internal audits.
• Experience working in a team matrix environment and navigating ambiguous, complex problems.

Culture & Benefits

• Health, dental, vision, life, disability, and flexible spending benefits.
• 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.