Senior Manager, Manufacturing

Role: Senior manufacturing leader responsible for site startup, clinical and commercial manufacturing readiness, and ongoing operations at ElevateBio's Pittsburgh facility. Objectives include executing startup projects, developing and revising manufacturing procedures, supporting digital systems and equipment implementation, and ensuring GMP compliance. Responsibilities encompass overseeing documentation, training, metrics, investigations, vendor onboarding, and participating in regulatory inspections and audits. The role also involves supporting on-floor operations as needed to meet business goals.

Qualifications: Bachelor's degree with 8+ years of related GMP manufacturing experience, or Master's with 6+ years, or PhD with 4+ years. Demonstrated leadership of cross-functional teams in GMP environments, preferably with experience supporting autologous/allogeneic cell or gene therapies and facility startups.

HighValue: Focus on cell and gene therapy manufacturing in GMP settings, site startup, digital systems implementation, regulatory interaction, and GMP compliance. The role requires on-site work with physical demands and flexibility for extended hours.

WorkSetup: On-site in Pittsburgh, with physical work requirements and potential for nights, weekends, and holidays to support business needs.