Bio Manufacturing Operator

Role Summary

Bio Manufacturing Operator at Elwood, KS. Responsible for performing and documenting all tasks and activities associated with biologics manufacturing at the monoclonal antibody (mAb) facility, ensuring cGMP compliance, aseptic processing, and participation in process improvements and interfacing with QC for sampling and environmental monitoring.

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

• Good mechanical aptitude.
• Understanding of sterile techniques and aseptic processes.

Education

• Associate or Bachelor’s degree in a biomanufacturing related discipline (e.g., biology, chemistry, engineering).

Additional Requirements

• Location: Elwood, KS (Onsite).
• Shift: 12-hour schedule – 5:00 AM to 5:00 PM or 5:00 PM to 5:00 AM, including every other weekend; weekend work with a 4% premium; non-shift hours with 10% premium.