Bio Manufacturing Operator

Role Summary

Bio Manufacturing Operator at Elwood, KS. Perform and document all tasks associated with biologics manufacturing at a monoclonal antibody (mAb) facility, ensuring cGMP compliance in a regulated environment and maintaining a sterile environment.

Responsibilities

• Execute and monitor core mAb manufacturing processes (media/buffer prep, upstream/downstream processing, formulation, fill/finish, secondary packaging).
• Maintain cGMP compliance in a regulated environment (USDA/FDA/EMA).
• Follow SOPs and batch records precisely for equipment operation, processing, and daily tasks.
• Perform aseptic manipulations and maintain a sterile environment.
• Support equipment preparation, maintenance, and process improvements, while interfacing with QC for sampling and environmental monitoring.

Qualifications

• Education: High School Diploma or equivalent.
• Minimum 2 years' experience in a regulated, commercial GMP biomanufacturing environment (relevant experience may include media and buffer preparation, cell culture, fermentation, aseptic processing, chromatography, TFF, final formulation, and fill/finish).
• Proficient in basic computer skills (Windows/Microsoft Office) and communication (written & verbal). Demonstrates teamwork, initiative, a strong work ethic, and a positive attitude.
• Must be able to wear appropriate gowning and personal protective equipment (PPE) in production and manufacturing support areas.

Skills

• aseptic technique
• Process monitoring and documentation
• cGMP regulatory awareness

Education

• Associate or Bachelor‚Äôs degree in a biomanufacturing related discipline (e.g., biology, chemistry, engineering) ‚Äî preferred.

Additional Requirements

• Location: Elwood, KS (Onsite).