This is an exciting opportunity responsible for overseeing Mammalian Cell Banking within a leading Biologics testing and manufacturing organization. You will be charged with overseeing Supervisors and Staff responsible for cell banking operations. You will also be responsible for the following activities:
* Overseeing GMP Manufacturing for both upstream cell culture and downstream purification processes.
* Overseeing mammalian cell banking operations including seed stocks and production in shake flasts, T-flasks, hyper flasks and cell stacks.
* Leading a team of Supervisors among multiple clean room suites as well as production and testing schedules.
* Overseeing and managing raw material and cell bank inventories.
* Overseeing virus production processes involving viral purification, Ultracentrifugation and TFF.
* Leading CAPAs, deviation handling and investigations.
* Providing guidance to clients and customers.
* Managing laboratory budgets, departmental budgets and expendatures.
* Ensuring inspection readiness and the hosting of FDA & EMEA audits and inspections.