GMP Manufacturing Site Lead – Startup & Compliance

elevatebio; Pittsburgh (Allegheny County); On-site; USD 120,000 - 180,000; Full time

Job summary

ElevateBio is seeking a manufacturing leader for our Pittsburgh facility to drive startup readiness and ongoing GMP operations for clinical and commercial manufacturing in the US and EU. The role requires partnering with MSAT, implementing digital systems, training programs, and supervising site manufacturing staff.

Initial focus is startup execution; later, oversight of documentation, training, metrics, investigations, and cross-functional projects, with occasional on-floor support to meet

Qualifications

• Bachelor's degree and at least 8 years of related experience, OR Master's degree, and at least 6 years of related experience OR a PhD with at least 4 years of experience.
• Experience supervising teams of people.
• Experience in a Manufacturing, Quality, or GMP environment supporting complex products; autologous/allogeneic cell therapies or gene therapies a plus.
• Experience with facility startup a plus.

Responsibilities

• Own manufacturing procedure revisions to reflect desired business processes.
• Represent the manufacturing function for digital system and equipment design and implementation projects
• Partner with MSAT on plans for initial tech transfer support and program onboarding
• Support planning and implementation of site training program and implementation of EM and aseptic programs
• Support procurement planning and execution including onboarding of gowning, manufacturing vendors, GMP cleaning processes etc.
• Review, trend and present data to senior management on manufacturing performance
• Oversee manufacturing deviation investigations for compliance and adherence to investigation best practices
• Participate in regulatory inspections and facility audits
• Support hiring and onboarding of site Manufacturing staff

Skills

Leadership

GMP experience

Cross-functional leadership

Project management

Education

Bachelor's degree in relevant field

Master's degree

PhD (with related experience)

Job description

ElevateBio is seeking a manufacturing leader for our Pittsburgh facility to drive startup readiness and ongoing GMP operations for clinical and commercial manufacturing in the US and EU. The role requires partnering with MSAT, implementing digital systems, training programs, and supervising site manufacturing staff.

Initial focus is startup execution; later, oversight of documentation, training, metrics, investigations, and cross-functional projects, with occasional on-floor support to meet