Biopharma Upstream Process Associate I/II

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

Job summary

KBI Biopharma, Inc. in Durham, NC is seeking a Manufacturing Associate I/II to perform upstream processing on a rotating 2-2-3 schedule with 12-hour shifts in a GMP/GLP environment.

You will follow approved procedures, help author SOPs/MBRs, write CAPAs, and ensure documentation supports quality and regulatory compliance. The role covers upstream unit operations (seed expansion, bioreactor operations, cell culture harvest) and requires collaboration with QA, MS&T, facilities, engineering, supply

Qualifications

• Requires Bachelor’s degree in a related scientific or engineering discipline or equivalent experience.
• Experience with cGMP manufacturing operations is preferred.
• Strong documentation and record-keeping skills per GMP/GLP standards.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records while complying with quality standards and regulations.
• Perform cleanroom operations including gowning and cleaning per GDP guidelines.
• Document tasks in manufacturing records and logbooks at time of execution.
• Operate and maintain manufacturing equipment according to SOPs.
• Ensure materials are issued and tracked during production records.
• Demonstrate understanding of cGMP and apply to tasks and responsibilities.
• Participate in workplace organization (5S) to maintain clean and compliant areas.

Skills

Upstream processing

GMP/GLP knowledge

Documentation

Team collaboration

Attention to detail

Quality systems

Education

Bachelor’s degree in science or engineering

High school diploma with related experience

Tools

MS Office

ERP

EDMS

Job description

KBI Biopharma, Inc. in Durham, NC is seeking a Manufacturing Associate I/II to perform upstream processing on a rotating 2-2-3 schedule with 12-hour shifts in a GMP/GLP environment.

You will follow approved procedures, help author SOPs/MBRs, write CAPAs, and ensure documentation supports quality and regulatory compliance. The role covers upstream unit operations (seed expansion, bioreactor operations, cell culture harvest) and requires collaboration with QA, MS&T, facilities, engineering, supply