Senior Night Bioprocess Specialist – GMP Manufacturing

KBI Biopharma, Inc.; Durham (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate I/II (Nights) to perform upstream or downstream bioprocessing and support operations. You will follow GMP/GLP, maintain documentation, and write SOPs/MBRs while ensuring Right First Time output.

The role requires knowledge of bioprocessing equipment, strong English communication, and the ability to work in a fast-paced 12-hour night shift. Cleanroom, cGMP, and safety compliance are essential.

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline with 4–6 years’ GMP manufacturing operations experience or high school with 7–10 years’ GMP ops experience.
• Bachelor’s degree with 5+ years’ GMP ops experience or high school with 10+ years’ GMP ops experience.
• Knowledge of upstream (cell culture/fermentation) or downstream (purification/bulk filling) operations preferred.
• Excellent written and verbal communication skills are required.
• Strong problem solving and mathematical reasoning abilities are essential.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records and quality standards.
• Operate in a cleanroom environment with aseptic processing controls.
• Document all manufacturing tasks in records and logbooks per GDP.
• Maintain and troubleshoot equipment per SOPs.
• Ensure materials are issued and accounted for during records execution.
• Demonstrate understanding of cGMP per task and responsibility.
• Participate in workplace organization (5S) and provide guidance to Manufacturing Associates.
• Assist supervisor to distribute workload and clarify task requirements.

Skills

Upstream processing

Downstream processing

Single-use platforms

Communication skills

Problem solving

Math skills

English proficiency

Education

Bachelor’s degree in related 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 bioprocessing and support operations. You will follow GMP/GLP, maintain documentation, and write SOPs/MBRs while ensuring Right First Time output.

The role requires knowledge of bioprocessing equipment, strong English communication, and the ability to work in a fast-paced 12-hour night shift. Cleanroom, cGMP, and safety compliance are essential.