Cell Culture Downstream Associate (Day Shift)

KBI Biopharma; North Carolina; On-site; USD 42,000 - 64,000; Full time

Job summary

KBI Biopharma is seeking a Manufacturing Associate I/II – Downstream to execute purification operations for early and late-phase cell culture programs in a GMP setting. You will follow SRs, EPRs, BRs and SOPs, maintaining GDP and cGMP compliance while handling chromatography, viral inactivation, ultrafiltration, and analytical tools.

The role requires strong attention to detail, excellent communication, and the ability to work a 12-hour schedule including weekends and holidays on the NC site.

Qualifications

• Must follow written instructions and GMP, GDP and GLP standards.
• Experience in a regulated industry or downstream/purification knowledge.
• Ability to work a 12-hour schedule including weekends and holidays.
• Excellent written and verbal communication skills.
• Must be organized with strong attention to detail.
• Biowork certification or related degree preferred.

Responsibilities

• Purification of cell culture products per manufacturing batch records using chromatography, filtration and viral reduction techniques.
• Operate in a cleanroom environment with aseptic processing controls and gowning procedures.
• Document all manufacturing tasks following GDP at time of execution.
• Ensure materials are issued and accounted for during production records.
• Demonstrate understanding of cGMP and how it applies to tasks.
• Participate in room 5S and maintain equipment per SOPs.

Skills

Attention to detail

Written and verbal communication

Instruction following

Energetic and motivated

Education

High school diploma

Associates or Bachelor’s degree in related field

Biowork certification

Tools

Cytiva UNICORN software

Job description

KBI Biopharma is seeking a Manufacturing Associate I/II – Downstream to execute purification operations for early and late-phase cell culture programs in a GMP setting. You will follow SRs, EPRs, BRs and SOPs, maintaining GDP and cGMP compliance while handling chromatography, viral inactivation, ultrafiltration, and analytical tools.

The role requires strong attention to detail, excellent communication, and the ability to work a 12-hour schedule including weekends and holidays on the NC site.