Night Downstream Cell-Culture Manufacturing Associate I/II

KBI Biopharma, Inc.; Durham (NC); On-site; USD 45,000 - 60,000; Full time

Benefits offered by this job

Career advancement opportunities

Challenging environment

Job summary

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II for night shifts (12 hours, 7PM–7AM) to support Upstream or Downstream cell culture operations in a GMP setting.

You will follow SRs, EPRs, BRs and SOPs, ensuring GMP, GDP and GLP compliance, with a focus on Right the First Time. The role involves aseptic technique, documentation, and operation of bioreactors and related equipment.

Qualifications

• Bachelor’s degree in a scientific or engineering field or 0-2 years GMP manufacturing experience.
• Experience with cell culture, fermentation or purification unit operations preferred.
• Excellent written and verbal communication in English is required.

Responsibilities

• Manufacture cell culture products per batch records in a GMP environment.
• Perform aseptic processing in a cleanroom with gowning and cleaning procedures.
• Document tasks in SRs, ERP and BRs following GDP at execution time.
• Review production records to ensure compliance and accuracy.

Skills

GMP knowledge

GDP/GLP

Aseptic processing

Documentation

English communication

Education

Bachelor’s degree in a related scientific or engineering discipline

High school diploma with GMP experience

Tools

Biosafety Cabinets

Single Use Bioreactors

Chromatography Columns

Ultrafiltration Skids

pH meters

Incubators

Job description

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II for night shifts (12 hours, 7PM–7AM) to support Upstream or Downstream cell culture operations in a GMP setting.

You will follow SRs, EPRs, BRs and SOPs, ensuring GMP, GDP and GLP compliance, with a focus on Right the First Time. The role involves aseptic technique, documentation, and operation of bioreactors and related equipment.