Microbiology Supervisor (Wednesday-Sunday, Second Shift)

NCBiotech; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

KBI Biopharma, Inc. seeks a microbiology laboratory leader to oversee testing and support for the contract manufacturing facility and process development.

You will manage programs like environmental monitoring, clean utility monitoring, and product testing while ensuring rigorous documentation and training. The role requires a strong GMP background, hands-on testing when needed, and the ability to train staff; onsite presence and 40% daily time in the laboratory are expected.

Qualifications

• Bachelor of Science 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 in Microbiology with 1 year related experience preferred.
• Knowledge of GMPs and biotechnology-derived product regulations; ability to react to change productively and handle other essential tasks.
• Strong orientation toward quality and customer service; high integrity and personal responsibility; strong collaboration and team-building skills.

Responsibilities

• Oversee testing and support for the Microbiology Laboratory in a Contract Manufacturing biotechnology facility and Process Development.
• Handle Environmental Monitoring (Air Viable, Total Air Particulate, Surface Viable), Clean Utility Monitoring (Water Sampling, Bioburden, Conductivity, TOC, Coliform and Nitrates), and Compressed Gas Monitoring (Collection, Air Viable, Total Air Particulate, Dragger Tests and specific ID tests).
• Perform Product Testing (Bioburd en, Endotoxin, Host Purity, or Non-Host), Media Release, and general Laboratory Support.
• Plan and execute routine microbial laboratory work; manage and develop staff; provide training for Quality Microbiology team; ensure documentation and technical writing; ensure method verifications and investigations are performed; maintain training records and proper labeling, handling, and storage of chemicals and biohazards; follow safety requirements.

Job description

*Please Note: This position is for Wednesday - Sunday, 12pm - 8pm*

Position Summary:

Responsible for overseeing for the testing and support for the Microbiology Laboratory in support of a Contract Manufacturing biotechnology facility and Process Development. Responsibilities includes 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
• Laboratory Support

It is the expectation that this position is required to be onsite full time. Addition, this position should be in the laboratory/facility for a minimum of 40% time daily.

Additional 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.
• Strong documentation and technical writing skills.
• Strong understands monitoring programs and methods and conducts troubleshooting analysis.
• Knowledge of current regulations and scientific literature.
• Ensures method verifications and qualifications protocols and investigations are performed appropriately. May execute testing when required.
• Maintains current state of training prior to execution of tasks.
• Strong working knowledge of sampling equipment and testing instruments.
• 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:

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 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

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.