Upstream Bioprocess Associate I

KBI Biopharma; Durham (NC); On-site; USD 42,000 - 66,000; Full time

Job summary

KBI Biopharma in Durham, NC is seeking a Manufacturing Associate I/II to perform upstream processing for biopharmaceutical products on a 2-2-3 day shift (7am-7pm). You will follow GMP and GLP, write SOPs/MBRs, CAPAs, and ensure Right First Time documentation.

Responsibilities include upstream unit operations, cleanroom work, GDP, equipment maintenance, and cross-functional collaboration with QA, MS&T, facilities, and supply chain. Strong attention to detail and integrity required.

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline.
• 0–5 years of relevant cGMP manufacturing experience.
• Excellent written and verbal communication skills.

Responsibilities

• Manufacture bulk intermediates per batch records in a GMP environment.
• Document tasks in records and logbooks; follow GDP.
• Maintain equipment and perform routine maintenance per SOP.
• Support 5S and cross-functional teams to ensure compliant operations.

Skills

Written and verbal communication

GMP knowledge

Attention to detail

Team collaboration

Problem solving

Education

Bachelor’s degree in a related scientific or engineering discipline

Tools

MS Office

ERP

EDMS

Production equipment software

Job description

KBI Biopharma in Durham, NC is seeking a Manufacturing Associate I/II to perform upstream processing for biopharmaceutical products on a 2-2-3 day shift (7am-7pm). You will follow GMP and GLP, write SOPs/MBRs, CAPAs, and ensure Right First Time documentation.

Responsibilities include upstream unit operations, cleanroom work, GDP, equipment maintenance, and cross-functional collaboration with QA, MS&T, facilities, and supply chain. Strong attention to detail and integrity required.