Senior Manager, Manufacturing
Core
Lead manufacturing operations and startup for a new cell/gene therapy facility, ensuring GMP compliance and supporting clinical/commercial production.
Role type
Senior Manager, Manufacturing Operations
Builds
New manufacturing facility for US and EU markets
Domain
Biotechnology / Advanced Therapies (Cell & Gene Therapy)
Required skills
GMP facility operations, manufacturing procedure development, digital system implementation, deviation investigation, regulatory inspection support, team supervision, cross-functional leadership
Preferred skills
Autologous/allogeneic cell therapy experience, gene therapy experience, facility startup experience
Technologies
GMP systems, digital manufacturing systems
Responsibilities
Own manufacturing procedure revisions, represent manufacturing in digital system projects, support tech transfer and program onboarding, implement training and aseptic programs, review manufacturing performance data, oversee deviation investigations, participate in regulatory audits, support staff hiring
Seniority
Senior Manager, hands-on leadership