GMP Cell Culture Manufacturing Associate II

KBI Biopharma, Inc.; Durham (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC is seeking a Manufacturing Associate II to perform upstream or downstream production activities for cell culture programs within a GMP environment.

You will execute tasks per SOPs and batch records, participate in media preparation, bioreactor operations, chromatography, and drug substance filling, while maintaining documentation and compliance. The ideal candidate holds a bachelor’s degree in a related scientific field (or equivalent) with 2–5 years of GMP

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline with 2–5 years GMP manufacturing experience.
• Basic knowledge of cell culture, fermentation or purification unit operations; single-use platform experience preferred.
• Excellent written and verbal communication skills required.
• Must be organized and able to thrive in a fast-paced, multi-tasked environment.

Responsibilities

• Manufacture cell culture products per batch records ensuring quality and regulatory compliance.
• Perform cleanroom operations with aseptic controls, gowning and cleaning procedures.
• Document manufacturing procedures (e.g., SRs, EPRs, BRs) per GDP/GMP standards at time of execution.
• Ensure proper issuance and accountability of items in manufacturing records.
• Demonstrate and apply knowledge of cGMP in daily tasks.
• Maintain and uphold 5S standards in the manufacturing environment.
• Operate and maintain equipment per SOPs.

Skills

Cell culture knowledge

Fermentation operations

Aseptic techniques

GDP/GMP documentation

Communication skills

Education

Bachelor's degree in a related scientific discipline

High school diploma with GMP experience

Job description

KBI Biopharma, Inc. in Durham, NC is seeking a Manufacturing Associate II to perform upstream or downstream production activities for cell culture programs within a GMP environment.

You will execute tasks per SOPs and batch records, participate in media preparation, bioreactor operations, chromatography, and drug substance filling, while maintaining documentation and compliance. The ideal candidate holds a bachelor’s degree in a related scientific field (or equivalent) with 2–5 years of GMP