Microbiology Manager/Senior Microbiology Supervisor

KBI Biopharma•Durham, NC

4d•Onsite

About The Position

Responsible for supporting microbiological programs and testing activities for processes, instruments, and equipment, and for ensuring the effective use of materials, equipment, and personnel while developing products and processes at high quality levels. The role supports aspects of Environmental Monitoring, Clean Utility Monitoring, Compressed Gas Monitoring, Product Testing, Media Release, and Laboratory Support programs as directed by management. The position manages and develops employees, executes and reviews routine microbiology laboratory work, and may perform testing as required. It uses technical discretion to execute and interpret experiments that contribute to program goals, makes detailed observations, and performs advanced data analysis. The role also supports training, method verification and qualification, investigations, troubleshooting, documentation, and compliance with safety and hazardous-material handling requirements. This position is required to be onsite full time and to spend a minimum of 40% of its time in the laboratory.

Requirements

For the Supervisor level, a Bachelor of Science degree in a scientific discipline and 5–7 years of technical management experience; alternatively, a master’s degree and 3–5 years of experience, or a doctorate in Microbiology study and 1–3 years of related experience and/or equivalent training.
If applicable, at least 2 years of managerial experience.
Knowledge of GMPs and regulations for biotechnology-derived products.
Ability to react productively to change and handle other essential tasks as assigned.
Strong orientation toward Quality and Customer Service.
Demonstrated respect for individuals.
Demonstrated contribution to science in an appropriate area.
High level of integrity and personal responsibility.
Strong collaboration and team-building skills.
Current training status before performing assigned tasks.

Nice To Haves

Doctorate degree in Microbiology study and 1–3 years of related experience and/or equivalent training is described as preferred.

Responsibilities

Manage and develop employees.
Execute and review routine Microbial Laboratory work; perform testing when required.
Use technical discretion in executing and interpreting experiments that contribute to program goals.
Make detailed observations and carry out advanced data analysis.
Maintain strong documentation and technical writing.
Understand monitoring programs and methods, and conduct troubleshooting analysis.
Serve as a qualified trainer for the Quality Microbiology team and train 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 training status before executing tasks.
Ensure proper labeling, handling, and storage of chemicals and biohazards used in the laboratory.
Ensure proper labeling and disposition of hazardous waste in satellite areas; adhere to safety requirements and procedures and attend required safety and health training, including hazardous-waste handling.
Support Environmental Monitoring, including air viable, total air particulate, and surface viable monitoring.
Support Clean Utility Monitoring, including water sampling, bioburden, conductivity, TOC, and coliforms.
Support Compressed Gas Monitoring, including collection, air viable and total air particulate monitoring, Dragger tests, and specific identification tests.
Support Product Testing, including bioburden, endotoxin, host purity, or non-host testing.
Support Media Release and Laboratory Support programs.