Biopharma Manufacturing Associate I/II — Upstream/Downstream

KBI Biopharma; Boulder (CO); On-site; USD 54,000 - 76,000; Full time

Job summary

KBI Biopharma is seeking a Manufacturing Associate I/II to perform upstream or downstream processing of bulk intermediates and/or bulk drug substances in a GMP environment. You will follow approved procedures and maintain documentation to ensure Right First Time (RFT), with adherence to GDP and GLP where applicable.

The role involves aseptic operations in a cleanroom, equipment maintenance, and strict documentation practices.

Qualifications

• Bachelor's degree in a related scientific or engineering discipline or equivalent experience.
• 0–2 years' experience in related cGMP manufacturing operations for Associate I; 2–5 years for Associate II.
• Ability to work in a cleanroom and follow GDP at the time of execution.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records and quality standards.
• Perform operations in a cleanroom with aseptic controls including gowning and cleaning.
• Document tasks in manufacturing records and logbooks.
• Maintain equipment per SOP and ensure materials are issued and accounted for.
• Understand and apply cGMP requirements to tasks and responsibilities.
• Support 5S workplace organization.

Skills

GMP knowledge

Documentation skills

6S/5S

Education

Bachelor’s degree in science or engineering

High school diploma with related experience

Tools

Cleanroom equipment

Aseptic processing procedures

Job description

KBI Biopharma is seeking a Manufacturing Associate I/II to perform upstream or downstream processing of bulk intermediates and/or bulk drug substances in a GMP environment. You will follow approved procedures and maintain documentation to ensure Right First Time (RFT), with adherence to GDP and GLP where applicable.

The role involves aseptic operations in a cleanroom, equipment maintenance, and strict documentation practices.