Manufacturing Associate I/II- (Nights)
KBI BiopharmaDurham, North Carolina, United States
Posted April 3, 2026
Full Time
About the Company
KBI Biopharma is an award-winning biopharmaceutical contract services organization providing fully-integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally. With each of our 500+ client partners, we have worked closely to personalize and rapidly accelerate their drug development programs. Built upon a foundation of world-class analytical capabilities, we deliver efficient process development and clinical and commercial cGMP manufacturing services for mammalian and microbial programs. KBI is proud to be a JSR Life Sciences Company.
Job Description
Manufacturing Associate I/II will perform upstream or downstream production activities for early and late-phase cell culture programs in a GMP environment, executing tasks per SOPs, batch records, and GMP/GDP/GLP standards, ensuring compliance and accuracy.
Requirements
- Manufacture cell culture products according to manufacturing batch records while ensuring compliance with quality standards, company policies, and current regulations.
- Perform cleanroom operations, adhering to aseptic processing controls, including gowning and cleaning procedures.
- Document manufacturing procedures (e.g., SRs, EPRs, BRs) in compliance with Good Documentation Practices (GDP) at the time of execution.
- Ensure proper issuance and accountability of items used in manufacturing records (SR, EPR, BR).
- Demonstrate and apply knowledge of current Good Manufacturing Practices (cGMP) in daily tasks and responsibilities.
- Maintain and uphold 5S standards in the manufacturing environment.
- Operate and perform maintenance on equipment per applicable Standard Operating Procedures.
Benefits
- 401k Matching
- Retirement Plan
- Health Insurance
- Life Insurance
- Paid Time Off