Senior Manager, Manufacturing Science and Technology

The Senior Manager, Manufacturing Science Technology position is responsible for writing & implementing site & project specific validation master plans. He/she is responsible for directing validation managers & engineers. Responsibilities include personnel scheduling, forecasting project requirements, & preparation of validation master plans. The Senior Manager assures that facilities, laboratory equipment, utility systems & process equipment are validated calibrated & that reports are written. The Senior Manager is responsible for preparing & controlling the annual budget & for project coordination with MedImmune staff & outside consultants as necessary & direct day-to-day operations of validation services.brbrEssential Job Functions:brbr*Write site & project specific validation master plans.br*Manage on-going validation activities outlined in validation master plansbr*Direct the validation activities including start-up protocols, thermal studies, cleaning validation, process equipment & utilities. Also, direct validation of QC instruments & methods.br*Communicate effectively with supervisor & other departments workload, priorities, & issues to maintain validation schedulebr*Approve validation protocols & reportsbr*Provide technical expertise to resolve process & validation problemsbr*Support implementation of harmonized validation practices at all commercial sitesbr*Subject matter expert of validation program to regulatory agencies as necessary.br*Responsible for ensuring training of employees to assure up-to-date knowledge of practices & procedures.br*Controls the Validation Department budget.br*Develops a competent staff capable of implementing company & quality objectives.br*Communicate effectively to management across departments & staff goals, priorities & policy.brbrProcess Validation, Method Validation, Sterility Validation, IQ/OQ Experience, Cleaning Validation, Autoclave, Employee Supervision, Project Team Leader, Budget.brbr~BSP