Associate Director, Upstream Manufacturing (Biopharma)

Location: USA - NC - Durham - National Way; onsite work in a cGMP manufacturing biotechnology facility with clean room operations.

Company

hirify.global operates biopharmaceutical manufacturing facilities, including a new commercial GMP facility in Durham.

What you will do

• Lead upstream manufacturing startup, readiness, commissioning, qualification, and commercial production activities.
• Oversee upstream manufacturing staff, including supervisors and specialists, while hiring, training, coaching, and developing a high-performing team.
• Plan medium- and long-term production schedules and coordinate manufacturing support with MS&T, process development, QA, Maintenance, Engineering, AFS, and Microbiology.
• Ensure timely execution and review of procedures, batch records, logbooks, deviations, CAPAs, change controls, ERP orders, and compliance documentation.
• Drive process improvement, troubleshoot production and equipment issues, monitor metrics, and support audits and inspections as a subject matter expert.
• Maintain facility and equipment readiness through routine walkthroughs, work-order oversight, and clear accountability for operational standards.

Requirements

• Bachelor’s degree in life sciences or engineering with 15+ years of related GMP manufacturing experience, or a master’s degree with 13+ years of experience.
• 7+ years of leadership or supervisory experience.
• Knowledge of cell culture or fermentation unit operations; experience with single-use platform technology is preferred.
• Strong written and verbal communication, organization, problem-solving, and multitasking skills.
• Fluent English reading and writing skills are required.
• Ability to work in clean rooms, wear clean room attire, and oversee operations involving mechanical, chemical, electrical, noise, and trip-and-fall hazards.

Culture & Benefits

• Full-time employment in a commercial cGMP biopharmaceutical manufacturing environment.
• Work includes collaboration across manufacturing, quality, engineering, maintenance, process development, and microbiology functions.
• Use of cell culture, single-use bioreactor, laboratory, production, and manufacturing software systems.
• Equal opportunity workplace committed to workforce diversity.