Senior Biopharma Manufacturing Associate – Night Shift

KBI Biopharma, Inc.; Durham (NC); On-site; USD 70,000 - 95,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate I/II for a 12-hour night shift (6 PM–6 AM) on a rotating 2-2-3 schedule to perform upstream or downstream processing of bulk intermediates and drug substances.

The role requires strict GMP/GLP compliance, precise documentation, and collaboration across QA, MS&T, facilities, and engineering. The candidate will write SOPs or Master Batch Records, support CAPAs, and work with single-use equipment while ensuring readiness and quality in

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline; 4–6 years’ GMP manufacturing ops experience or high school diploma with 7–10 years’ GMP experience.
• Excellent written and verbal communication skills; able to read complex documents and write reports.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records in compliance with quality standards.
• Perform operations in a cleanroom environment with aseptic controls.
• Document tasks in manufacturing records and logbooks following GDP at execution time.
• Maintain and use equipment per applicable SOPs; assist with CAPAs and MBRs.

Skills

GMP experience

GLP experience

Written and verbal communication

Team collaboration

Problem solving

Education

Bachelor’s degree in science or 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 for a 12-hour night shift (6 PM–6 AM) on a rotating 2-2-3 schedule to perform upstream or downstream processing of bulk intermediates and drug substances.

The role requires strict GMP/GLP compliance, precise documentation, and collaboration across QA, MS&T, facilities, and engineering. The candidate will write SOPs or Master Batch Records, support CAPAs, and work with single-use equipment while ensuring readiness and quality in