Biopharma Manufacturing Associate II ( Day Shift )

KBI Biopharma; North Carolina; On-site; USD 48,000 - 68,000; Full time

Job summary

KBI Biopharma in North Carolina is seeking a Manufacturing Associate I/II to perform upstream or downstream bioprocessing in a GMP environment, following SOPs and master batch records to ensure Right First Time production.

The role includes 12-hour shifts on a 2-2-3 schedule, cleanroom operations, GDP-compliant documentation, and collaboration with QA, MS&T, facilities, and engineering to ensure reliable manufacturing.

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline with 0–2 years of cGMP manufacturing experience, or high school diploma with 3–5 years of experience.
• Manufacturing Associate II requires 2–5 years of related cGMP manufacturing experience or high school with 4–6 years.
• Experience with upstream (cell culture or fermentation) or downstream (purification and bulk filling) operations is preferred.
• Excellent written and verbal communication is required.
• Able to work 12-hour shifts in a GMP environment.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records.
• Perform operations in a cleanroom environment, applying aseptic controls.
• Document each task involving manufacturing records and logbooks following GDP.
• Utilize and perform maintenance on equipment per applicable SOP.
• Ensure all materials are issued and accounted for during execution.
• Demonstrate, apply, and ensure understanding of cGMP.
• Participate in workplace organization (5S).

Skills

Communication skills

Attention to detail

Team player

Problem solving

Safety compliance

Education

Bachelor’s degree in a related scientific or engineering discipline

Tools

MS Office

ERP

EDMS

Production equipment software

Job description

KBI Biopharma in North Carolina is seeking a Manufacturing Associate I/II to perform upstream or downstream bioprocessing in a GMP environment, following SOPs and master batch records to ensure Right First Time production.

The role includes 12-hour shifts on a 2-2-3 schedule, cleanroom operations, GDP-compliant documentation, and collaboration with QA, MS&T, facilities, and engineering to ensure reliable manufacturing.