Night Shift Purification Senior - Upstream/Downstream

KBI Biopharma, Inc.; Durham (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate I/II (Nights) to perform upstream or downstream processing of bulk intermediates and drug substances in a GMP-compliant cleanroom.

You will follow approved procedures, document activities, and support continuous improvement in manufacturing operations. Responsibilities include operating bioreactors, chromatography, tangential flow filtration, and bulk filling as needed, while maintaining 12-hour night shifts and working with QA,

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline or equivalent experience with GMP manufacturing.
• Experience working in GMP manufacturing operations and documenting processes.
• Excellent written and verbal communication skills are required.
• Ability to read, interpret, and follow SOPs and batch records.
• Knowledge of cGMP, GDP, and aseptic processing is preferred.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records in compliance with quality standards.
• Operate in a cleanroom environment with aseptic processing controls.
• Document tasks in manufacturing records and logbooks per GDP requirements.
• Provide direction to Manufacturing Associates and support workload distribution.
• Collaborate cross-functionally with QA, MS&T, facilities, engineering, and IT.

Skills

GMP manufacturing

GLP knowledge

Documentation

Team collaboration

Problem solving

English proficiency

Education

Bachelor’s degree in science/engineering

High school diploma with GMP experience

Tools

MS Office

ERP

EDMS

Production equipment software

Job description

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate I/II (Nights) to perform upstream or downstream processing of bulk intermediates and drug substances in a GMP-compliant cleanroom.

You will follow approved procedures, document activities, and support continuous improvement in manufacturing operations. Responsibilities include operating bioreactors, chromatography, tangential flow filtration, and bulk filling as needed, while maintaining 12-hour night shifts and working with QA,