Night Shift Senior Manufacturing Associate II — GMP Ops

NCBioImpact; North Carolina; On-site; USD 85,000 - 110,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate II for night shift to perform downstream processing and support manufacturing operations in a GMP-compliant environment.

The role involves working with chromatography, filtration, viral inactivation, and bulk filling under controlled procedures. The position requires a Bachelor’s degree with 5+ years of GMP experience and strong documentation, communication, and problem-solving skills.

Qualifications

• Bachelor’s degree with 5+ years’ GMP manufacturing experience.
• Knowledge of upstream or downstream unit operations preferred.
• Excellent written and verbal communication skills.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records.
• Perform operations in a cleanroom environment with aseptic processing controls.
• Document tasks following GDP and GMP protocols.
• Operate and maintain equipment per SOPs.
• Ensure materials are issued and accounted for during records.
• Apply cGMP concepts to tasks and responsibilities.
• Support workplace organization (5S) and cross-functional communication.
• Provide guidance to Manufacturing Associates and assist supervisor with workload.

Skills

GMP knowledge

GLP knowledge

SOP writing

CAPA writing

Team collaboration

Education

Bachelor’s degree in science/engineering

Tools

ERP systems

EDMS

Production software

Job description

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate II for night shift to perform downstream processing and support manufacturing operations in a GMP-compliant environment.

The role involves working with chromatography, filtration, viral inactivation, and bulk filling under controlled procedures. The position requires a Bachelor’s degree with 5+ years of GMP experience and strong documentation, communication, and problem-solving skills.