Bioprocess Manufacturing Associate II

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

Job summary

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II to perform upstream or downstream processing of bulk intermediates and drug substances in a GMP environment.

You will follow approved procedures, document work, and participate in CAPA and change control as needed. The role requires 12-hour shifts, potential overnight work, and collaboration across QA, MS&T, facilities, and engineering to ensure compliant, reliable manufacturing operations.

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline with 0–2 years’ experience in cGMP manufacturing; or high school degree with 3–5 years’ experience.
• Bachelor’s degree for II with 2–5 years’ experience in related cGMP manufacturing operations; or high school degree with 4–6 years’ experience.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records and in compliance with quality standards.
• Perform operations in a cleanroom environment with aseptic processing controls.
• Document each task involving manufacturing records and logbooks following GDP at time of execution.
• Maintain and operate equipment per applicable SOP.
• Ensure materials are issued and accounted for during record execution.
• Demonstrate understanding of cGMP applicable to tasks and responsibilities.
• Participate in workplace organization (5S).

Skills

Attention to detail

Written and verbal communication

Team player

English literacy

Problem solving

Mathematical ability

Education

Bachelor’s degree in a related scientific or engineering discipline

High school diploma with related cGMP experience

Tools

MS Office

ERP

EDMS

Job description

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II to perform upstream or downstream processing of bulk intermediates and drug substances in a GMP environment.

You will follow approved procedures, document work, and participate in CAPA and change control as needed. The role requires 12-hour shifts, potential overnight work, and collaboration across QA, MS&T, facilities, and engineering to ensure compliant, reliable manufacturing operations.