Microbiology Supervisor (Wednesday-Sunday, Second Shift)

KBI Biopharma•Durham, NC

4d•Onsite

About The Position

Responsible for overseeing the testing and support for the Microbiology Laboratory in support of a Contract Manufacturing biotechnology facility and Process Development. Responsibilities include laboratory support, program testing, reporting of results, development and execution of protocols and reports. 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, Coliform and Nitrates), 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, and Laboratory Support. It is the expectation that this position is required to be onsite full time. Additionally, this position should be in the laboratory/facility for a minimum of 40% time daily. Additional Responsibilities include planning and executing routine Microbial Laboratory work, utilizing technical discretion in the execution and interpretation of experiments that contribute to program goals, and potentially performing testing when required. This role involves employee management and development, making detailed observations, and carrying out intermediate data analysis. The qualified candidate will serve as a trainer for the Quality Microbiology team and perform training for staff on programs as needed. Strong documentation and technical writing skills are essential, along with a strong understanding of monitoring programs and methods, and the ability to conduct troubleshooting analysis. Knowledge of current regulations and scientific literature is required. The role ensures method verifications and qualifications protocols and investigations are performed appropriately. The candidate must maintain current training prior to task execution and possess a strong working knowledge of sampling equipment and testing instruments. Responsibilities also include ensuring proper labeling, handling, and storage of all chemical and biohazards used in the laboratory, ensuring proper labeling and disposition of hazardous waste in satellite areas, adhering to all safety requirements, following safe procedures, and attending all required safety and health training, including handling hazardous waste.

Requirements

Minimum requirement is a Bachelor of Science degree in a scientific discipline with a minimum of 4 – 5 years of technical management experience; or a master’s degree with 3 years or a Doctorate degree in Microbiology study and 1 year related experience and/or equivalent training preferred.
This person will have 0 + years' experience in managerial experience.
Must have knowledge of GMPs and biotechnology-derived product regulations.
Must be able to react to change productively and handle other essential tasks as assigned.
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.
Strong documentation and technical writing skills.
Strong understands monitoring programs and methods and conducts troubleshooting analysis.
Knowledge of current regulations and scientific literature.
Strong working knowledge of sampling equipment and testing instruments.

Responsibilities

Plan and execute routine Microbial Laboratory work.
Utilizes technical discretion in the execution and interpretation of experiments that contribute to program goals.
May perform testing when required.
Employee management and development.
Makes detailed observations and carries out intermediate data analysis.
Qualified trainer for the Quality Microbiology team and performs training for staff on programs as needed.
Ensures method verifications and qualifications protocols and investigations are performed appropriately.
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.