Pfizer Director of Aseptic Operations in Kalamazoo, Michigan

ROLE SUMMARY•This position will be required to lead the Pfizer Kalamazoo aseptic drug product manufacturing function in a cGMP compliant environment. The leader will be responsible for Component Preparation, Product Formulation, Aseptic Filling, Freeze Dry, Biologic Active Ingredients, and Operations Compliance functions.•The leader will ensure that manufacturing methods / environment will meet contemporary industrial, Regulatory and Pfizer standards. He or she will work with the department leaders to ensure that departments are properly staffed to meet production requirements, to create and monitor budgets, to monitor and control production variances and ensure a safe working environment. The position will be responsible to interact with the sites quality assurance, quality control, validation, engineering, technology services, supply chain and regulatory departments in order ensure that regulatory standards, company policies and site processes are met.•This individual will cultivate and reinforce appropriate Pfizer values, norms, and behaviors and will provide oversight to individuals and teams on personal development, performance, and quality related issues. The position will provide oversight of the manufacturing teams and will write and deliver performance reviews and perform second level reviews as required.ROLE RESPONSIBILITIESDirect the manufacture of aseptic drug products across three aseptic cores, ten formulation suites, twelve filling lines and twenty five freeze dryers, as well as all associated capital and product transfer project support. Ensure that the manufacturing departments are cGMP compliant. Ensure that the departments are staffed to meet production requirements. Creates, monitors and responsible for achieving department's budget. Monitors, reports and reacts accordingly to production variance reports. Ensures a safe manufacturing environment is in place. Ensures that all manufacturing methods and practices are consistent with industry and Pfizer standards. Interacts with the sites quality assurance, quality control, validation, engineering, technology services, supply chain and regulatory departments to ensure the sites manufacturing needs, regulatory standards and company policies are met. Ensures that colleague training programs are suitable and effective to support cGMP requirements. Drive effective CAPA at key suppliers to improve quality compliance and efficiency of componentry.Timely escalation of personnel, environmental, safety and manufacturing issues. Provide strategic direction for operations master planning, preparation of business justifications with direct input to capital investments, and oversee product transfers. Work across multiple functions and manage multiple competing priorities and requirements, including performing site and functional responsibilities. Note that these activities may not be time bound to core hours or presence at the site.BASIC QUALIFICATIONS•Bachelor's degree in Engineering, Science, or equivalent•15 years of directly related experience and at least 5 years in an aseptic drug product manufacturing environment•10+ years of experience leading direct reports•Minimum of 5 years of managerial experience directing and developing staff level colleagues•Strong analytical, presentation and relationship management skills•Experience in aseptic drug product processes•Proven track record of delivering results consistently while being a role model for the Pfizer Leader Behaviors.•Strong knowledge of cGMPs (US EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to a pharmaceutical production facilityPREFERRED QUALIFICATIONS•Excellent verbal, written and presentation skills&#