Senior Director, MS&T (Biologics)

Location: USA - NC - Durham - National Way

Company

hirify.global provides biopharmaceutical manufacturing and process development services.

What you will do

• Direct tech transfer, process validation, process engineering, and support laboratory activities for the MS&T department.
• Lead commercial product introduction from Stage 2 PPQ through Stage 3 CPV process validation and Pre-Approval Inspection.
• Drive clinical product introduction and tech transfer in collaboration with Process Development.
• Establish scalable procedures, business processes, tools, and industry best practices for tech transfer and manufacturing operations.
• Collaborate with Quality, Supply Chain, Facilities, Engineering, Manufacturing, and Process Development to execute projects on schedule.
• Manage and develop a multidisciplinary team of engineers and scientists, including hiring, training, performance management, and career development.

Requirements

• BS in Science or Engineering with at least 18 years of industry experience, a Master's degree with 16 years, or a PhD with 14 years.
• Demonstrated expertise in biologics upstream or downstream processing and operations.
• Expertise in tech transfer, process validation, process engineering, and biological process optimization and scale-up.
• Experience collaborating with Process Development, Quality, Supply Chain, Engineering, and Manufacturing.
• Knowledge of industry best practices, boards of health guidelines, cGMP compliance, and engineering standards.
• Experience with cGMP production operations is required.

Nice to have

• Experience working in a cGMP manufacturing environment.

Culture & Benefits

• Cross-functional collaboration with manufacturing, quality, supply chain, engineering, and process development teams.
• Opportunity to support revenue growth, risk mitigation, cost-of-goods optimization, and sustainable manufacturing practices.
• Responsibility for representing the department in client meetings, audits, board of health meetings, and discussions with senior management.