Cell Culture GMP Manufacturing Associate

KBI Biopharma, Inc.; Durham (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

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

You will execute tasks per SOPs, batch records and GDP/GLP standards while maintaining cleanroom controls and thorough documentation. The role emphasizes basic cell culture/fermentation/purification operations knowledge, strong communication skills, and the ability to work in a fast-paced setting with a positive,

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline; GMP manufacturing experience preferred.
• Basic understanding of cell culture, fermentation or purification unit operations; single-use platform experience preferred.
• Strong written and verbal communication skills; able to work in fast-paced environment.

Responsibilities

• Manufacture cell culture products per batch records while complying with quality standards and regulations.
• Perform cleanroom operations and aseptic processing controls, including gowning and cleaning procedures.
• Document manufacturing procedures (SRs, EPRs, BRs) per GDP practices at the time of execution.
• Ensure issuance and accountability of items used in manufacturing records (SR, EPR, BR).
• Demonstrate knowledge of cGMP in daily tasks and maintain 5S standards.

Skills

Cell culture

Fermentation

Purification

Single-use platform

Documentation

Education

Bachelor's degree in a related scientific or engineering discipline

Tools

MS Office

ERP

EDMS

Job description

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

You will execute tasks per SOPs, batch records and GDP/GLP standards while maintaining cleanroom controls and thorough documentation. The role emphasizes basic cell culture/fermentation/purification operations knowledge, strong communication skills, and the ability to work in a fast-paced setting with a positive,