TheMicrobiologySpecialistwill be part of theMicrobiologyDepartment responsiblefor thetesting and support for the Microbiology Laboratory in support of a Contract Manufacturing biotechnology facility and Process Development. Responsibilitiesincludeslaboratory support, program testing, reporting of results,development and execution of protocols and reports.

Thisperson 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

Additional Responsibilities:

• 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.
• Plan 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.
• Strong understands monitoring programs and methods and conducts troubleshooting analysis. 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.
• Develop and execute method verifications and qualifications protocols and investigations are performed appropriately. May execute testing when required.
• Familiarity with current regulations and scientific literature.

Qualifications:Specialist I Experience:
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.

Specialist II Experience:
Minimum requirement is a Bachelor of Science degree in a scientific discipline with a minimum of 7 - 10 years of technical management experience; or a master's degree with 5 - 8 years or a Doctorate degree in Microbiology study and 3 - 6 years related experience and/or equivalent training preferred. If applicable, this person will have a minimum of 2 years' managerial experience.
Generic:

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

Salary Range:

80,000-115,000K

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.

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.

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

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.