Cell Culture Biopharma Manufacturing Associate

KBI Biopharma, Inc.; Durham (NC); On-site; USD 52,000 - 75,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC seeks 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 and batch records, conduct aseptic operations, and support chromatography, ultrafiltration, and fill processes, while maintaining GDP/GLP compliance. The role requires strong written and spoken English, a proactive, organized approach, and the ability to work 12‑hour shifts on a 2‑2‑3

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline with 0-2 years GMP manufacturing experience; OR high school diploma with 3-5 years GMP manufacturing experience.
• Manufacturing Associate II: Bachelor’s degree with 2-5 years GMP experience; or high school diploma with 4-6 years GMP experience.
• Fluent in English with strong written and verbal communication; able to work in a fast-paced, organized manner.

Responsibilities

• Manufacture cell culture products per batch records while ensuring compliance with quality standards and regulations.
• Perform cleanroom operations, aseptic controls, gowning and cleaning procedures.
• Document manufacturing procedures (SRs, EPRs, BRs) in GDP-compliant records.
• Ensure proper issuance and accountability of materials used in records.
• Demonstrate knowledge of cGMP in daily tasks and responsibilities.
• Maintain 5S standards and upkeep of manufacturing equipment.

Skills

Cell culture knowledge

Fermentation operations

Purification operations

Written communication

Verbal communication

Organizational skills

GMP awareness

Education

Bachelor’s degree in related scientific or engineering discipline

High school diploma with GMP experience

Tools

Single-use bioreactors

Chromatography systems

Ultrafiltration systems

MS Office / ERP / EDMS

Job description

KBI Biopharma, Inc. in Durham, NC seeks 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 and batch records, conduct aseptic operations, and support chromatography, ultrafiltration, and fill processes, while maintaining GDP/GLP compliance. The role requires strong written and spoken English, a proactive, organized approach, and the ability to work 12‑hour shifts on a 2‑2‑3