GMP Cell Culture Manufacturing Associate I/II

KBI Biopharma, Inc.; North Carolina; On-site; USD 55,000 - 72,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II to execute upstream or downstream production activities in a GMP environment.

You will work across media preparation, bioreactor setup, cell culture harvest, aseptic technique, chromatography, and fill operations, ensuring adherence to cGMP, GDP, and GLP with a strong ownership mindset. The role requires following SR’s, EPR’s, BR’s and SOPs, while maintaining accurate production records and contributing to a safe, compliant

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline with GMP exposure.
• Experience in GMP manufacturing operations or related field preferred.
• Strong written and verbal communication in English.

Responsibilities

• Manufacture cell culture products per batch records in compliance with quality standards.
• Perform aseptic operations in a cleanroom including gowning and cleaning procedures.
• Document tasks following GDP and record-keeping standards.
• Ensure items are issued and accounted for during execution of records.
• Apply understanding of cGMP and participate in room 5S and equipment maintenance.

Skills

GMP knowledge

GDP

GLP

Aseptic processing

English fluency

Education

Bachelor’s degree in a related scientific or engineering discipline

Tools

Single Use Bioreactors

Chromatography

Ultrafiltration

Filling systems

Pumps and meters

Job description

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II to execute upstream or downstream production activities in a GMP environment.

You will work across media preparation, bioreactor setup, cell culture harvest, aseptic technique, chromatography, and fill operations, ensuring adherence to cGMP, GDP, and GLP with a strong ownership mindset. The role requires following SR’s, EPR’s, BR’s and SOPs, while maintaining accurate production records and contributing to a safe, compliant