Bioprocess Manufacturing Associate II

KBI Biopharma; Durham (NC); On-site; USD 42,000 - 56,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC, seeks Manufacturing Associate I/II to perform upstream or downstream processing of bulk intermediates and drug substances. Responsibilities include following GMP/GxP, writing SOPs or Master Batch Records, and ensuring Right First Time (RFT).

The role involves 12‑hour shifts on a 2‑2‑3 schedule, collaboration with QA, MS&T, facilities, engineering, and supply chain to maintain compliant, reliable manufacturing operations.

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline or equivalent experience.
• 0-2 years’ experience in related cGMP manufacturing operations for Associate I; 2-5 years for Associate II.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records and quality standards.
• Perform operations in a cleanroom with aseptic controls.
• Document tasks in production records and logbooks per GDP.
• Maintain and operate equipment per applicable SOP.
• Ensure materials are issued and accounted for during records.
• Apply cGMP knowledge to tasks and responsibilities.
• Participate in workplace organization (5S).

Skills

GMP knowledge

SOP writing

CAPA writing

Documentation

Team collaboration

Upstream/Downstream ops

Education

Bachelor’s degree in sciences/engineering

Tools

MS Office

ERP

EDMS

Job description

KBI Biopharma, Inc. in Durham, NC, seeks Manufacturing Associate I/II to perform upstream or downstream processing of bulk intermediates and drug substances. Responsibilities include following GMP/GxP, writing SOPs or Master Batch Records, and ensuring Right First Time (RFT).

The role involves 12‑hour shifts on a 2‑2‑3 schedule, collaboration with QA, MS&T, facilities, engineering, and supply chain to maintain compliant, reliable manufacturing operations.