Night Shift Bioprocess Manufacturing Associate I/II

KBI Biopharma; Durham (NC); On-site; USD 52,000 - 76,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II (Nights) to perform upstream or downstream production activities for cell culture programs in a GMP environment.

Responsibilities include executing tasks per SOPs, batch records, and GDP/GLP standards while maintaining process ownership and thorough documentation. Candidates should have basic knowledge of cell culture, fermentation, or purification, with preference for single-use platform technology.

Qualifications

• Bachelor's degree in a related scientific or engineering discipline with 0-2 years of GMP manufacturing experience; OR high school diploma with 3-5 years of related GMP manufacturing experience.
• Bachelor's degree in a related scientific or engineering discipline with 2-5 years of GMP manufacturing experience; OR high school diploma with 4-6 years of related GMP manufacturing experience.

Responsibilities

• 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.

Job description

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II (Nights) to perform upstream or downstream production activities for cell culture programs in a GMP environment.

Responsibilities include executing tasks per SOPs, batch records, and GDP/GLP standards while maintaining process ownership and thorough documentation. Candidates should have basic knowledge of cell culture, fermentation, or purification, with preference for single-use platform technology.