Cell Culture Bioprocess Operator (Day Shift)

KBI Biopharma, Inc.; North Carolina; On-site; USD 42,000 - 62,000; Full time

Job summary

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

Responsibilities include following SOPs, batch records, aseptic techniques, chromatography, and bioreactor operations, with a focus on quality, documentation, and process ownership. The role requires basic cell culture or fermentation knowledge, strong English communication, and the ability to thrive in a fast-paced setting.

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 with 2–5 years GMP manufacturing experience; OR high school diploma with 4–6 years of 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 in compliance with GDP at the time of execution.
• Ensure proper issuance and accountability of items used in manufacturing records.
• Demonstrate and apply knowledge of cGMP in daily tasks and responsibilities.
• Maintain and uphold 5S standards in the manufacturing environment.
• Operate and perform maintenance on equipment per SOPs.
• Basic knowledge of cell culture, fermentation or purification unit operations; experience with single-use platform technology preferred.
• Energetic, motivated and dynamic individual; must be organized and able to work in a fast-paced, multitasking environment.

Skills

Cell culture basics

Single-use platform

Communication skills

Organized

Fast-paced adaptability

Education

Bachelor's degree in science/engineering

High school diploma + GMP experience

Tools

MS Office

ERP

EDMS

Production equipment software

Job description

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

Responsibilities include following SOPs, batch records, aseptic techniques, chromatography, and bioreactor operations, with a focus on quality, documentation, and process ownership. The role requires basic cell culture or fermentation knowledge, strong English communication, and the ability to thrive in a fast-paced setting.