Biopharma Upstream Manufacturing Associate I

KBI Biopharma, Inc.; Durham (NC); On-site; USD 52,000 - 76,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II to perform upstream processing for biopharmaceutical products on a 2-2-3 day shift (7am-7pm). The role emphasizes GMP/GLP adherence, accurate documentation, and collaboration with QA, facilities, and other departments to ensure compliant operations.

The candidate should have a scientific or engineering background with experience in cGMP environments and strong communication skills to thrive in a fast-paced biopharma setting.

Qualifications

• Bachelor's degree in a related scientific or engineering discipline required.
• 0-2 years’ experience in related cGMP manufacturing operations (Associate I) or 2-5 years’ experience (Associate II).
• Experience in upstream (cell culture or fermentation) unit operations preferred.
• Excellent written and verbal communication skills required.
• Reading, interpreting safety, SOPs, batch records; writing routine reports.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records in a GMP environment.
• Operate in cleanroom with aseptic processing controls.
• Document tasks in manufacturing records and logbooks.
• Maintain equipment per SOP and ensure materials are issued/ accounted for.
• Support 5S workplace organization and cross-functional collaboration.

Skills

Bachelor's degree in science/engineer

GMP manufacturing operations

Single-use platform technology

Excellent written and verbal沟

Fluent in English

Upstream cell culture/fermentation

Good documentation practices

Education

Bachelor's degree in related scientific or engineering discipline

High school diploma with relevant experience

Tools

MS Office

ERP

EDMS

Job description

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II to perform upstream processing for biopharmaceutical products on a 2-2-3 day shift (7am-7pm). The role emphasizes GMP/GLP adherence, accurate documentation, and collaboration with QA, facilities, and other departments to ensure compliant operations.

The candidate should have a scientific or engineering background with experience in cGMP environments and strong communication skills to thrive in a fast-paced biopharma setting.