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

KBI Biopharma, Inc.; Durham (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Microbiology Associate II to join the Microbiology Department on a Sunday-Thursday, second shift. The role supports contract manufacturing and process development through environmental monitoring, product testing, and lab-based data reporting.

The candidate will perform routine microbial work, analyze results, and help troubleshoot testing programs. Onsite work, safety training, and adherence to regulations are required to ensure compliant laboratory operations.

Qualifications

• Bachelor of Science in Microbiology or related field with cGMP exposure.
• 2–3 years of relevant cGMP experience OR Master’s with 1 year OR PhD with 0 years.
• Ability to read, analyze, and interpret technical procedures and regulations.

Responsibilities

• Perform routine microbial laboratory testing and reporting of results.
• Support environmental monitoring, clean utility, and product testing programs.
• Maintain proper labeling, handling and disposal of hazardous materials; ensure safety compliance.

Skills

Laboratory testing

Data analysis

Technical writing

Education

B.S. in Microbiology

Tools

LIMS

Job description

*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.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.