Night-Shift Biotech Manufacturing Associate II

KBI Biopharma; Durham (NC); On-site; USD 60,000 - 85,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Manufacturing Associate II (Nights) in Durham, NC to execute Upstream or Downstream production activities within a GMP environment. The role supports early/late-phase cell culture programs, following SRs, EPRs, BRs, SOPs, and GDP/GxP standards.

The candidate will perform aseptic processing in a cleanroom, document tasks, maintain records, and apply cGMP knowledge. Night shifts required in a fast-paced facility with strict quality controls.

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline with 2–5 years of GMP manufacturing experience.
• High school diploma with 4–6 years GMP manufacturing experience acceptable alternative.
• Experience with cell culture, fermentation or purification unit operations preferred.
• Excellent written and verbal communication skills; ability to work in a fast-paced GMP environment.

Responsibilities

• Manufacture cell culture products per batch records in compliance with quality standards and regulations.
• Perform operations in a cleanroom environment with aseptic processing, including gowning and cleaning procedures.
• Document each task following GDP at the time of execution (SRs, EPRs, BRs).
• Ensure all items are issued and accounted for during execution of a record (SR, EPR, BR).
• Demonstrate understanding of cGMP and participate in room 5S activities.

Skills

Communication skills

Fluent English

Read & write documents

Problem solving

Education

Bachelor’s degree in science or engineering

High school diploma with GMP experience

Tools

MS Office

ERP

EDMS

Job description

KBI Biopharma, Inc. is seeking a Manufacturing Associate II (Nights) in Durham, NC to execute Upstream or Downstream production activities within a GMP environment. The role supports early/late-phase cell culture programs, following SRs, EPRs, BRs, SOPs, and GDP/GxP standards.

The candidate will perform aseptic processing in a cleanroom, document tasks, maintain records, and apply cGMP knowledge. Night shifts required in a fast-paced facility with strict quality controls.