Upstream Bioprocess Associate I/II

KBI Biopharma, Inc.

Durham (NC)

Hybrid

USD 55,000 - 70,000

Full time

14 days+

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Job summary

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II to support upstream processing for biopharmaceutical products. The role requires following approved procedures under GMP/GLP, contributing to Master Batch Records, CAPAs, and equipment qualification.

The candidate will work in a cleanroom, document activities, and collaborate with QA, MS&T, facilities, and other teams. The position emphasizes ownership of production processes, adherence to records, and cross-functional teamwork to

Qualifications

Bachelor’s degree in a related scientific or engineering discipline with 0–2 years’ experience in cGMP manufacturing operations; or high school degree with 3–5 years’ experience, or equivalent.
Associate II requires 2–5 years’ experience in cGMP manufacturing operations; or high school degree with 4–6 years’ experience, or equivalent.
Knowledge of upstream (cell culture or fermentation) operations is preferred.

Responsibilities

Manufacture bulk intermediates and drug substances per batch records in compliance with quality standards.
Perform operations in a cleanroom environment with aseptic processing controls.
Document tasks in manufacturing records and logbooks per GDP.
Maintain equipment per SOP and ensure proper material accounting.
Demonstrate understanding of cGMP and participate in 5S workplace organization.