Cell Culture Manufacturing Associate I/II

KBI Biopharma; United States; On-site; USD 52,000 - 78,000; Full time

Job summary

KBI Biopharma, Inc. seeks a Manufacturing Associate I/II to perform upstream or downstream production activities in a GMP environment for cell culture programs. You will follow SOPs, batch records, GDP/GLP standards, and maintain cleanroom operations and 5S in a fast-paced setting.

The role requires basic cell culture/fermentation knowledge, strong documentation, and excellent communication. Shift is 12 hours (7 AM–7 PM) on a 2-2-3 schedule, with opportunities to grow within manufacturing

Qualifications

• Bachelor's degree in a related scientific or engineering discipline or equivalent GMP experience.
• Strong documentation skills and adherence to GDP/GLP standards.
• Basic knowledge of cell culture, fermentation, or purification operations.

Responsibilities

• Manufacture cell culture products according to batch records and quality standards.
• Perform cleanroom operations with proper aseptic processing controls.
• Document manufacturing procedures in GDP/GLP compliant records.
• Ensure proper issuance and accountability of items used in manufacturing records.
• Apply cGMP knowledge in daily tasks and maintain 5S standards.

Skills

Cell culture basics

GMP manufacturing

Documentation GDP/GLP

Aseptic techniques

Single-use platform tech

Education

Bachelor's degree in related scientific/engineering discipline

High school diploma with GMP experience

Tools

MS Office

ERP

EDMS

Job description

KBI Biopharma, Inc. seeks a Manufacturing Associate I/II to perform upstream or downstream production activities in a GMP environment for cell culture programs. You will follow SOPs, batch records, GDP/GLP standards, and maintain cleanroom operations and 5S in a fast-paced setting.

The role requires basic cell culture/fermentation knowledge, strong documentation, and excellent communication. Shift is 12 hours (7 AM–7 PM) on a 2-2-3 schedule, with opportunities to grow within manufacturing