Microbiology Specialist I (Wednesday-Saturday, 2nd Shift)
KBI Biopharma
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.
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, 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. In addition, this position should be in the laboratory a minimum of 40%.
Position Responsibilities
- Utilizes technical discretion in the execution and interpretation of experiments that contribute to program goals.
- May perform testing when required.
- Understands monitoring programs and methods and conducts troubleshooting analysis.
- Develop and execute method verifications and qualification protocols and investigations are performed appropriately. May execute testing when required.
- Makes detailed observations and carries out advanced data analysis. Qualified trainer for the Quality Microbiology team and performs training for staff on programs as needed.
- Familiarity with current regulations and scientific literature. 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. Execute and review routine Microbial Laboratory work.
Minimum Requirements
- 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.
Requirements
- Bachelor of Science degree in a scientific discipline with 5-7 years of technical management experience; or Master's degree with 3-5 years; or Doctorate in Microbiology with 1-3 years related experience
- Proficiency in microbiological methods and current regulatory standards
- Experience with environmental monitoring, clean utility monitoring, compressed gas monitoring, product testing (bioburden, endotoxin, host purity), media release, and laboratory support
- Ability to develop and execute method verifications and qualification protocols
- Strong data analysis and troubleshooting skills
- Familiarity with current regulations and scientific literature
- Knowledge of proper labeling, handling, and storage of chemical and biohazards
- Experience with hazardous waste management and laboratory safety
Company overview
KBI Biopharma is an award-winning global contract development and manufacturing organization (CDMO) that provides fully integrated, accelerated drug development and biologics manufacturing services to pharmaceutical and biotechnology companies worldwide. Founded in 1996 and now part of JSR Life Sciences, KBI has established itself as a next-generation CDMO specializing in complex biologics. The company serves over 500 client partners and has supported the advancement of more than 160 drug candidates from preclinical stages to market, including the manufacture of ten commercial products. KBI's comprehensive service portfolio includes cell line development, process development, analytical services, formulation development, and clinical and commercial cGMP manufacturing for both mammalian and microbial programs. With strategically located facilities across the United States and Europe, KBI leverages world-class analytical capabilities and proprietary platforms like SUREtechnology™ and PUREplatform™ to deliver personalized, accelerated solutions for biopharmaceutical development. The company is recognized for its scientific excellence, quality manufacturing, and commitment to helping clients bring innovative medicines to patients faster.