Day-Shift Upstream Bioprocess Associate

KBI Biopharma; Durham (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II to perform upstream processing in a GMP-compliant biopharma facility.

You will follow approved procedures, work on seed expansion, bioreactor operations, and write SOPs/MBRs while ensuring Right First Time execution. The role requires 12-hour shifts (including nights) in a cleanroom setting, strong documentation, and collaboration with QA, facilities, and engineering to maintain compliant manufacturing operations.

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline and 0-2 years’ experience in related cGMP manufacturing operations; or high school degree and 3-5 years’ experience, or equivalent.
• Bachelor’s degree in a related scientific or engineering discipline and 2-5 years’ experience in related cGMP manufacturing operations; or high school degree and 4-6 years’ experience, or equivalent.
• All Levels: Basic knowledge of upstream (cell culture or fermentation) unit operations is preferred. Experience in single-use platform technology is preferred. Excellent written and verbal communication skills are required. Energetic, motivated, and dynamic individual.

Responsibilities

• Manufacture bulk intermediates and drug substances per manufacturing batch records and in compliance with quality standards, company policies and current regulations.
• Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures.
• Document each task involving manufacturing records and logbooks following GDP at the time of execution.
• Utilize and perform maintenance on equipment per applicable SOP.
• Ensure all materials are issued and accounted for during the execution of a record (i.e. SR, EPR and BR).
• Demonstrate, apply, and ensure understanding of cGMP and how it applies to specific tasks and responsibilities.
• Participate and be accountable for workplace organization (5S).

Skills

Upstream processing

GMP knowledge

Documentation

Teamwork

Education

Bachelor's degree in related science or engineering

Tools

MS Office

ERP

EDMS

Job description

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II to perform upstream processing in a GMP-compliant biopharma facility.

You will follow approved procedures, work on seed expansion, bioreactor operations, and write SOPs/MBRs while ensuring Right First Time execution. The role requires 12-hour shifts (including nights) in a cleanroom setting, strong documentation, and collaboration with QA, facilities, and engineering to maintain compliant manufacturing operations.