Night Shift Downstream Manufacturing Associate (GMP)

KBI Biopharma, Inc.; Town of Russia (NY); On-site; USD 33,000 - 43,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II – Downstream to execute purification activities for cell culture programs in a GMP environment.

The role involves using chromatography, viral reduction, ultrafiltration, and single-use systems, while maintaining strict cGMP/GDP/GxP compliance and accurate documentation. The position requires a high attention to detail, ability to follow instructions, and flexibility to work a 12-hour shift (6p–6a) including weekends and holidays.

Qualifications

• Must follow GMP, GDP and GLP requirements and Right the First Time.
• Experience in downstream or purification unit operations.
• Able to work a 12-hour schedule to include weekends, nights and holidays.
• Must maintain high attention to detail and strong documentation practices.

Responsibilities

• Purification of cell culture products per batch records using chromatography and filtration techniques.
• Perform operations in a cleanroom with aseptic controls and gowning.
• Document all manufacturing steps in SR, ERP and BR according to GDP.
• Verify materials and records are complete and traceable during execution.
• Demonstrate understanding of cGMP and how it applies to tasks.
• Support room 5S and routine equipment maintenance per SOPs.

Skills

Experience in regulated industry or 
p

Downstream/purification operations

Ability to follow written instructions

Excellent written and verbal comms

Organized and detail-oriented

Able to work 12-hour shifts including

Education

Associates or Bachelor’s degree in a related scientific or engineering discipline

Job description

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II – Downstream to execute purification activities for cell culture programs in a GMP environment.

The role involves using chromatography, viral reduction, ultrafiltration, and single-use systems, while maintaining strict cGMP/GDP/GxP compliance and accurate documentation. The position requires a high attention to detail, ability to follow instructions, and flexibility to work a 12-hour shift (6p–6a) including weekends and holidays.