Cell Culture Manufacturing Associate I/II

KBI Biopharma; Durham (NC); On-site; USD 42,000 - 66,000; Full time

Job summary

KBI Biopharma is seeking a Manufacturing Associate I/II to execute upstream or downstream production activities in a GMP environment. You will follow SR/EPR/BR documentation, maintain cleanroom controls, and ensure GDP/GxP compliance in a fast-paced biotech setting.

You will gain exposure to media/buffer prep, shake flasks, bioreactors, chromatography, ultrafiltration, and filling operations, while reviewing production records for accuracy.

Qualifications

• Bachelor's degree in a related scientific or engineering discipline with 0-2 years' GMP manufacturing experience.
• Bachelor's degree in a related scientific or engineering discipline with 2-5 years' GMP manufacturing experience.

Responsibilities

• Manufacture cell culture products per manufacturing batch records in compliance with quality standards, company policies and current regulations.
• Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures.
• Document each task involving manufacturing procedures (i.e. SR's, EPR's and BR's) following GDP at the time of execution.
• Ensure all items are issued and accounted for during the execution of a record (i.e. SR, EPR and BR)
• Demonstrate and apply understanding of current Good Manufacturing Practices (cGMP) and how they apply to specific tasks and responsibilities.
• Participate and be accountable for room 5S.
• Utilize and perform maintenance on equipment per applicable SOP.

Skills

Cell culture knowledge

Communication skills

Organized and multi-tasked

English fluency

Problem solving

MS Office / ERP / EDMS

Equipment operation

Education

Bachelor's degree in science/engineering (0-2 yrs GMP ops)

High school diploma + 3-5 yrs GMP ops

Bachelor's degree in science/engineering (2-5 yrs GMP ops)

High school diploma + 4-6 yrs GMP ops

Tools

MS Office

ERP

EDMS

Production equipment software

Job description

KBI Biopharma is seeking a Manufacturing Associate I/II to execute upstream or downstream production activities in a GMP environment. You will follow SR/EPR/BR documentation, maintain cleanroom controls, and ensure GDP/GxP compliance in a fast-paced biotech setting.

You will gain exposure to media/buffer prep, shake flasks, bioreactors, chromatography, ultrafiltration, and filling operations, while reviewing production records for accuracy.