Senior Night Shift Cell Culture Manufacturing Associate

KBI Biopharma, Inc.; Durham (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

KBI Biopharma, Inc. seeks a Manufacturing Associate I/II (Nights) in Durham, NC. You will perform Upstream or Downstream production activities for cell culture programs, following GMP batch records and GDP/GLP standards in a fast-paced facility.

Qualifications include a scientific/engineering degree or equivalent GMP experience, plus aseptic processing and documentation skills. Night shifts run 7PM–7AM on a 2-2-3 schedule with 12-hour shifts.

Qualifications

• Bachelor's degree in a related scientific or engineering discipline with 0–2 years GMP manufacturing experience or high school diploma with 3–5 years GMP experience.
• Experience in cleanroom operations and aseptic processing controls.
• Strong written and verbal communication; able to document batch records and SOPs.

Responsibilities

• Manufacture cell culture products according to batch records while ensuring compliance with quality standards and regulations.
• Perform cleanroom operations and aseptic processing controls, including gowning.
• Document manufacturing procedures (SRs, EPRs, BRs) in GDP at time of execution.
• Ensure proper issuance and accountability of items used in manufacturing records.
• Demonstrate knowledge of cGMP in daily tasks.
• Maintain 5S standards in the manufacturing environment.
• Operate and maintain equipment per SOPs.
• Basic knowledge of cell culture, fermentation or purification unit operations; single-use platform experience preferred.

Skills

GMP manufacturing

Cell culture

Aseptic techniques

Documentation

5S

Communication

Education

Bachelor's degree in a related scientific or engineering discipline

High school diploma with GMP experience

Tools

Single-use platform

Chromatography

Ultrafiltration

GDP/EDMS

Job description

KBI Biopharma, Inc. seeks a Manufacturing Associate I/II (Nights) in Durham, NC. You will perform Upstream or Downstream production activities for cell culture programs, following GMP batch records and GDP/GLP standards in a fast-paced facility.

Qualifications include a scientific/engineering degree or equivalent GMP experience, plus aseptic processing and documentation skills. Night shifts run 7PM–7AM on a 2-2-3 schedule with 12-hour shifts.