Microbiology Associate II (Sunday-Thursday, 2nd Shift)

KBI Biopharma; Durham (NC); On-site; USD 60,000 - 90,000; Full time

Job summary

KBI Biopharma is seeking a Microbiology Associate II to support environmental monitoring, bioburden, endotoxin, and other product testing in a Sunday-Thursday second shift. The role demands strong lab skills, data interpretation, and strict adherence to cGMP and safety protocols.

Responsibilities include executing routine microbial work, documenting results, and maintaining compliance with regulatory standards while spending most of the day in the laboratory or manufacturing facility.

Qualifications

• Bachelor of Science in a scientific discipline with 2–3 years of cGMP experience; or a Master's with 1 year; or a PhD with 0 years.
• Ability to read, analyze, and interpret technical procedures and regulations; write reports and procedures.
• Must be able to lift up to 50 lbs and wear PPE; onsite, full-time role.

Responsibilities

• Execute routine microbial laboratory work and interpret experiments.
• Make detailed observations and perform elementary data analysis.
• Understand monitoring programs and troubleshoot analyses.
• Operate sampling equipment and testing instruments.
• Documentation and technical writing of results and procedures.
• Maintain knowledge of current regulations and scientific literature.

Skills

Data analysis

Technical writing

Laboratory skills

cGMP experience

Education

Bachelor of Science in a scientific discipline

Master's degree in a relevant field

PhD in Microbiology

Tools

LIMS

Job description

Please Note: This is a Sunday-Thursday, Second Shift position*

Please Note: This is a Sunday-Thursday, Second Shift position*

JOB SUMMARY

The Microbiology Associate II will be part of the Microbiology Department responsible for 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, and execution of protocols.

This position 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

This position requires full-time onsite attendance. Employees are expected to spend approximately 75% or more of their workday in the laboratory or manufacturing facility.

Job Responsibilities

• Execute routine Microbial Laboratory work. Utilize technical discretion in the execution and interpretation of experiments that contribute to program goals.
• Make detailed observations and perform elementary data analysis.
• Understand monitoring programs and methods and conduct troubleshooting analysis.
• Working knowledge of sampling equipment and testing instruments.
• Documentation and technical writing skills.
• Knowledge of current regulations and scientific literature.
• Ensure 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

• Education: Minimum requirement is a Bachelor of Science degree in a scientific discipline with a minimum of 2 - 3 years of relevant cGMP experience; OR master's degree with 1 year of relevant cGMP experience; OR a PhD in Microbiology and 0 years related experience.
• Knowledge, Skills, Abilities: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and governmental regulations. Ability to write reports, business correspondence, and procedures. Ability to effectively present information and respond to questions from groups of managers and peers.
• Language Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.
• Reasoning Ability: Ability to apply advanced mathematical concepts such as exponents, logarithms, statistical analysis, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.
• Physical Demands: Must be able to lift up to 50lbs. Ability to stand for periods of time greater than 3 hours. Position requires donning PPE.
• Computer Skills: LIMS experience preferred, Word processing, Spreadsheets, Internet, E-mail
• Equipment Use: Computer, telephone, Sampling equipment and Laboratory instruments.
• Please Note: This is a Sunday-Thursday, Second Shift position*

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.