Microbiology Manager/Senior Microbiology Supervisor

KBI Biopharma•Durham, NC
•Onsite

About The Position

Responsible for supporting microbiological programs and testing activities for processes, instruments, and equipment, and for ensuring effective use of materials, equipment, and personnel while developing products and processes at high quality levels. The role supports management-directed programs covering environmental monitoring; clean utility monitoring; compressed gas monitoring; product testing; media release; and laboratory support. The position is required to be onsite full time and spend at least 40% of its time in the laboratory. It includes employee management and development, execution and review of routine microbiology laboratory work, technical interpretation and analysis, staff training, and oversight of method verification, qualification protocols, and investigations. The role also maintains laboratory safety, chemical and biohazard handling, hazardous-waste practices, and required training.

Requirements

  • For the Supervisor level, a bachelor's degree in a scientific discipline and 5–7 years of technical management experience; or a master's degree and 3–5 years of experience; or a doctorate in microbiology and 1–3 years of related experience and/or equivalent training.
  • At least 2 years of managerial experience, if applicable.
  • Knowledge of GMPs and regulations for biotechnology-derived products.
  • Demonstrated 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.
  • Ability to react productively to change and handle other essential tasks as assigned.

Responsibilities

  • Support microbiological programs and testing activities for processes, instruments, and equipment.
  • Ensure effective use of materials, equipment, and personnel while developing products and processes at high quality levels.
  • Support environmental monitoring, including air viable, total air particulate, and surface viable testing.
  • Support clean utility monitoring, including water sampling, bioburden, conductivity, TOC, and coliform testing.
  • Support compressed gas monitoring, including collection, air viable and total air particulate testing, Dragger tests, and specific identification tests.
  • Support product testing, including bioburden, endotoxin, host purity, or non-host testing.
  • Support media release and the laboratory.
  • Manage and develop employees.
  • Execute and review routine microbiology laboratory work; perform testing when required.
  • Use technical discretion to execute and interpret experiments that contribute to program goals.
  • Make detailed observations and conduct advanced data analysis.
  • Prepare and maintain strong technical documentation and writing.
  • Apply knowledge of 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.
  • Ensure method verifications, qualification protocols, and investigations are performed appropriately.
  • Maintain current training qualifications before executing tasks.
  • Ensure proper labeling, handling, and storage of laboratory chemicals and biohazards.
  • Ensure proper labeling and disposition of hazardous waste in satellite areas; follow safety procedures and attend required safety and health training, including hazardous-waste handling.
  • React productively to change and handle other essential tasks as assigned.
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