Microbiology Manager/Senior Microbiology Supervisor

About the role

Responsible for supporting microbiological programs and testing activities for processes, instruments and equipment. Ensures the effective use of material, equipment and personnel while developing products and processes at high quality levels. This position is required to be onsite full time and should be in the laboratory a minimum of 40%.

• Environmental Monitoring (Air Viable, Total Air Particulate, Surface Viable)
• Clean Utility Monitoring (Water Sampling, Bioburden, Conductivity, TOC, Coliforms)
• Compressed Gas Monitoring (Collection, Air Viable, Total Air Particulate, Dragger Tests and specific ID tests)
• Product Testing (Bioburden, Endotoxin, Host Purity, or Non-Host)
• Media Release
• Laboratory Support

Responsibilities

• Employee management and development
• Execute and review routine Microbial Laboratory work
• Utilize technical discretion in the execution and interpretation of experiments that contribute to program goals
• Perform testing when required
• Make detailed observations and carry out advanced data analysis
• Strong documentation and technical writing skills
• Strong understanding of monitoring programs and methods; conduct troubleshooting analysis
• Serve as qualified trainer for the Quality Microbiology team and perform training for staff on programs as needed
• Maintain familiarity with current regulations and scientific literature
• Ensure method verifications, qualification protocols, and investigations are performed appropriately
• Maintain current state of training prior to execution of tasks
• Ensure proper labeling, handling, and storage of all chemical and biohazards used in the laboratory
• Ensure proper labeling and disposition of hazardous waste in satellite areas; adhere to all safety requirements and follow safe procedures
• Attend all required safety and health training, including handling hazardous waste

Requirements

For Supervisor: Minimum requirement is a Bachelor of Science degree in a scientific discipline with a minimum of 5–7 years of technical management experience; or a master's degree with 3–5 years; or a Doctorate degree in Microbiology study and 1–3 years related experience and/or equivalent training preferred. If applicable, this person will have a minimum of 2 years' managerial experience. Must have knowledge of GMPs and biotechnology-derived product regulations and be able to react to change productively and handle other essential tasks as assigned.

Also requires a demonstrated track record in the following areas:

• Strong orientation for Quality and Customer Service
• Demonstrated level of respect for individuals
• Demonstrated contribution to science in appropriate area
• High level of integrity and personal responsibility
• Strong Collaboration and Team building skills