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Job #02713

About our client Our client is a rapidly growing pharmaceutical company headquartered in the Midwest that is focused on the development and commercialization of therapeutic radio-pharmaceuticals for the US nuclear medicine market. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Supervisor, Microbiology Midwest, USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead the Microbiology Department and develop programs, processes and procedures 2) Maintain quality and facilities to ensure regulatory compliance and provide regulatory guidance in the application of their job 3) Establish and comply with proper documentation and training in compliance with 21 CFR Part 210 and 211 4) Implement systems and procedures focused on process improvement and defect prevention (as related to microbiology and sterility insurance) 5) Demonstrate and promote company’s vision 6) Pursue efficiency improvements and cost-reduction efforts consistent with regulatory compliance 7) Issue, investigate and follow-up on environmental reports such as EAN/EAR/EIR to ensure use 8) Ensure that all reports are closed within 14 days (to support site product release goals) 9) Evaluate incident and decision for sampling 10) Implement EM program improvement initiatives to ensure compliance with FDA, PDA and ISO requirements 11) Facilitate the Environmental Monitoring Team, including data review and analysis, maintaining EM data-trending spreadsheets, preparing graphs and reports for the team, management review, etc. 12) Apply Good Laboratory and Manufacturing Practices in all areas 13) Work as a technical resource for micro, manufacturing and validations for aseptic processing and EM Requirements 1) BS in Science (Life Science curriculum such as Biology, Microbiology preferred) 2) Experience in microbiology lab operations with a minimum of 3 – 5 years of service experience 3) Experience in microbiological principles and applications related to microbial ID, validation and clean-room technology 4) Trained in cGMP for laboratory operations and compliance to regulatory guidelines 5) Working knowledge of microbial ID systems, (VITEK, Biolog, etc.), USP sterility and bioburden test methods, including use of Vaporized Hydrogen Peroxide (VHP) technology 6) Extensive knowledge of Environmental Monitoring (EM) programs preferred 7) Ability to assertively interact with people at all levels in the organization 8) Strong interpersonal, analytical and prioritization skills 9) Demonstrated technical writing skills