Night Shift Cell Culture GMP Technician II

KBI Biopharma, Inc.; Durham (NC); On-site; USD 55,000 - 78,000; Full time

Job summary

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

You will follow SOPs and batch records, work in cleanroom settings, and document actions per GDP and cGMP standards. The role emphasizes ownership, accuracy, and organization within a fast-paced facility, involving bioreactor operations, chromatography, ultrafiltration, and filling steps.

Qualifications

• Bachelor's degree in a scientific or engineering discipline; 2–5 years of GMP manufacturing experience, or a high school diploma with 4–6 years GMP experience.
• Basic knowledge of cell culture, fermentation, or purification unit operations preferred.
• Experience in single-use platform technology preferred.
• Excellent written and verbal communication skills required.
• Energetic, motivated and dynamic; highly organized in a fast-paced environment.

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.

Skills

Cell culture

Fermentation

Purification

Single-use platform

Communication skills

Organization

Education

Bachelor's degree in a related scientific or engineering discipline

High school diploma with 4-6 years GMP manufacturing experience

Tools

SOPs

Job description

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

You will follow SOPs and batch records, work in cleanroom settings, and document actions per GDP and cGMP standards. The role emphasizes ownership, accuracy, and organization within a fast-paced facility, involving bioreactor operations, chromatography, ultrafiltration, and filling steps.