Shift Schedule
Please note: This position is for Wednesday - Sunday, 12pm - 8pm.
Position Summary
Responsible for overseeing 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, development and execution of protocols and reports.
Program Areas
- 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
Key Responsibilities
- Plan and execute routine microbial laboratory work using technical discretion for program goals.
- Utilize technical expertise to execute and interpret experiments, including testing when required.
- Manage employee development and conduct detailed observations and intermediate data analysis.
- Serve as a qualified trainer for the Quality Microbiology team and provide training on programmes.
- Ensure proper labeling, handling, and storage of all chemicals and biohazards, and proper disposal of hazardous waste.
- Adhere to safety requirements, complete required safety and health training, and follow safe procedures.
- Maintain current training status prior to task execution and ensure method verification, qualification protocols, and investigations are performed appropriately.
- Demonstrate strong documentation and technical writing skills.
- Understand monitoring programmes and methods, conduct troubleshooting analysis, and stay knowledgeable of current regulations and scientific literature.
Minimum Requirements
- Bachelor of Science degree in a scientific discipline with a minimum of 4–5 years of technical management experience, or a Master’s degree with 3 years of experience, or a Doctorate in Microbiology with 1 year related experience and/or equivalent training.
- 0+ years of managerial experience.
- Knowledge of GMPs and biotechnology-derived product regulations.
- Ability to react to change productively and handle other essential tasks as assigned.
- Track record in the following areas:
- Strong orientation for Quality and Customer Service
- Demonstrated respect for individuals
- Demonstrated contribution to science in appropriate area
- High level of integrity and personal responsibility
- Strong collaboration and team building skills
Benefits & Development
We offer employees a challenging, rewarding, and fast‑paced environment along with the opportunity for career advancement through the development of one’s technical skills. Employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.
EEO Statement
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce.
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