Microbiology Manager/Senior Microbiology Supervisor

Position Summary

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 person is responsible for the aspects of the following programs as directed by management:

• 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

It is the expectation that this position is required to be onsite full time. Additionally, this position should be in the laboratory a minimum of 40%.

Position Responsibilities

• Employee management and development.
• Execute and review routine Microbial Laboratory work. Utilizes technical discretion in the execution and interpretation of experiments that contribute to program goals. May perform testing when required.
• Makes detailed observations and carries out advanced data analysis.
• Strong documentation and technical writing skills.
• Strong understanding of monitoring programs and methods and conducts troubleshooting analysis.
• Qualified trainer for the Quality Microbiology team and performs training for staff on programs as needed.
• Familiarity with current regulations and scientific literature.
• Ensures method verifications and qualification protocols and investigations are performed appropriately. May execute testing when required.
• Maintains current state of training prior to execution of tasks.
• Ensures proper labeling, handling, and storage of all chemical and biohazards used in the laboratory. Ensures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures and attends all required safety and health training, including handling hazardous waste.

Minimum 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