Upstream Bioprocess Manufacturing Associate (I/II)

KBI Biopharma, Inc.; Durham (NC); On-site; USD 60,000 - 90,000; Full time

Job summary

KBI Biopharma, Inc. seeks a Manufacturing Associate I/II to perform upstream processing for biopharmaceutical products.

On a 2-2-3 rotating schedule (dayshift, 7am-7pm), you will follow approved procedures to ensure Right First Time production, maintain strict GMP/GLP documentation, and support SOPs/MBRs. You will work with QA, MS&T, facilities, and other departments to ensure reliable, compliant operations.

Qualifications

• Excellent written and verbal communication skills required.
• Fluent in reading and writing English.
• Ability to read and interpret safety rules and batch records.
• Ability to write routine reports and correspondence.
• Ability to speak effectively to groups.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records in compliance with quality standards.
• Perform operations in a cleanroom environment with aseptic processing controls.
• Document tasks in manufacturing records and logbooks following GDP.
• Utilize and perform maintenance on equipment per applicable SOP.
• Demonstrate understanding of cGMP in assigned tasks and participate in 5S.

Skills

Communication skills

Reading/writing English

Numerical ability

Reasoning ability

Mathematical calculations

Education

Bachelor’s degree in a scientific or engineering discipline

High school diploma

Job description

KBI Biopharma, Inc. seeks a Manufacturing Associate I/II to perform upstream processing for biopharmaceutical products.

On a 2-2-3 rotating schedule (dayshift, 7am-7pm), you will follow approved procedures to ensure Right First Time production, maintain strict GMP/GLP documentation, and support SOPs/MBRs. You will work with QA, MS&T, facilities, and other departments to ensure reliable, compliant operations.