Night Shift Cell Culture Bioprocess Associate I/II

KBI Biopharma, Inc.; North Carolina; On-site; USD 52,000 - 78,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II (Nights) to perform downstream production activities for cell culture programs in a GMP environment. You will follow SOPs and batch records, perform cleanroom operations, and document procedures per GDP/GMP standards, while maintaining 5S and quality controls.

The role requires basic knowledge of cell culture, fermentation, or purification operations and strong communication in a fast-paced, multitasking setting.

Qualifications

• Bachelor's degree in a related scientific or engineering discipline; GMP manufacturing experience preferred.
• Associate I: 0–2 years GMP experience; Associate II: 2–5 years GMP experience.
• Basic knowledge of cell culture, fermentation or purification unit operations preferred.
• Experience with single-use platform technology preferred.

Responsibilities

• Manufacture cell culture products according to batch records while complying with quality standards and regulations.
• Perform cleanroom operations with aseptic processing controls and gowning procedures.
• Document procedures (SRs, EPRs, BRs) per GDP standards during execution.
• Ensure proper issuance and accountability of items used in records.
• Apply cGMP knowledge in daily tasks and maintain 5S cleanliness.
• Operate and maintain equipment per SOPs.

Job description

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II (Nights) to perform downstream production activities for cell culture programs in a GMP environment. You will follow SOPs and batch records, perform cleanroom operations, and document procedures per GDP/GMP standards, while maintaining 5S and quality controls.

The role requires basic knowledge of cell culture, fermentation, or purification operations and strong communication in a fast-paced, multitasking setting.