Operational Readiness Manager – Mammalian Manufacturing
Core
Strategic architect for a massive facility expansion and retrofit project to double mammalian manufacturing capacity, bridging engineering design with long-term commercial sustainability.
Role type
Senior capital project leader / Operational Readiness Manager
Builds
A new 6K bioprocessing facility and operational readiness blueprints for a facility doubling in capacity
Domain
Biotechnology / Mammalian cell culture manufacturing / Pharmaceutical facility construction
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP manufacturing execution, early-stage asset execution, organizational design, stakeholder management, bioprocessing technical acumen, budget governance, risk mitigation
Preferred skills
PMP certification, FDA/EMA regulatory experience
Technologies
GMP workflows, automated systems, technical transfer frameworks
Responsibilities
Define and execute operational readiness strategy from demolition through commercial validation; stress-test facility designs against GMP workflows; synchronize cross-functional teams across engineering, QA, and construction; architect organizational design and talent pipelines; manage $25M readiness budget; mitigate execution risks for seamless hand-off to commercial operations
Seniority
Senior, hands-on IC with strategic scope
