Job Description

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. Additionly, 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 understand 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

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.