Manufacturing Start-Up Lead – GMP Cell Therapy

ElevateBio; Waltham (IL); On-site; USD 120,000 - 160,000; Full time

Job summary

ElevateBio in Pittsburgh seeks an experienced manufacturing leader to direct site startup activities and oversee GMP manufacturing readiness for US and EU markets. You’ll drive procedural changes, digital systems implementations, and cross-functional programs, while transitioning to long-term oversight of manufacturing operations, training, documents, and investigations in a matrixed environment.

This role requires collaboration with MSAT, QA, engineering and external partners; prior leadership

Qualifications

• Bachelor’s degree plus 8+ years in manufacturing leadership within GMP or cell/gene therapy contexts.
• Experience supervising teams and coordinating cross-functional projects.
• Experience with facility startup is a plus.

Responsibilities

• Own site manufacturing procedures and revise documents to reflect new processes.
• Represent manufacturing in digital system and equipment design projects.
• Lead tech transfer planning with MSAT and onboarding programs.
• Support site training program development and implementation of EM and aseptic programs.
• Oversee vendor onboarding, GMP cleaning, and gowning processes.
• Review data, identify trends, and report to senior management.
• Participate in regulatory inspections and facility audits.
• Assist in hiring and onboarding site Manufacturing staff.

Skills

Team leadership

GMP manufacturing

Cross-functional collaboration

Regulatory inspections

Education

Bachelor’s degree in a life sciences or engineering field

Master’s degree in related field

PhD in life sciences

Job description

ElevateBio in Pittsburgh seeks an experienced manufacturing leader to direct site startup activities and oversee GMP manufacturing readiness for US and EU markets. You’ll drive procedural changes, digital systems implementations, and cross-functional programs, while transitioning to long-term oversight of manufacturing operations, training, documents, and investigations in a matrixed environment.

This role requires collaboration with MSAT, QA, engineering and external partners; prior leadership