Senior Manager, Manufacturing (Cell & Gene Therapy)

Location: On-site in Pittsburgh, Pennsylvania, United States

Company

hirify.global is a technology-driven biotechnology company helping partners develop advanced therapies from design through commercialization.

What you will do

• Execute the Manufacturing site startup plan and prepare a new facility for clinical and commercial manufacturing in US and EU markets.
• Own manufacturing procedure revisions and support functional protocols, reports, digital systems, equipment design, and implementation projects.
• Partner with MSAT on initial technology transfer support and program onboarding.
• Support training, environmental monitoring, aseptic programs, procurement, vendor onboarding, and GMP cleaning processes.
• Review and present manufacturing performance data, oversee deviation investigations, and participate in regulatory inspections and facility audits.
• Support hiring and onboarding of site Manufacturing staff.

Requirements

• Bachelor’s degree with at least 8 years of related experience, Master’s degree with at least 6 years, or PhD with at least 4 years.
• Experience supervising teams and leading cross-functional teams in a matrixed organization.
• Experience in Manufacturing, Quality, or a GMP environment supporting complex products.
• Ability to work on site and support nights, weekends, and holidays as needed.
• Ability to stand, walk, bend, stretch, lift 15–20 lbs, wear PPE, and perform repetitive physical tasks.

Nice to have

• Experience with autologous or allogeneic cell therapies or gene therapies.
• Experience with facility startup.

Culture & Benefits

• Regular employment within the Manufacturing department.
• Collaborative work with internal subject matter experts, external project teams, and cross-functional partners.
• Work supporting the development of advanced therapies and manufacturing capabilities.