Bio Manufacturing Operator

Role Summary

Bio Manufacturing Operator at Elwood, KS. Responsible for performing and documenting tasks associated with biologics manufacturing at the monoclonal antibody (mAb) facility. The role requires following cGMP in a regulated environment and supporting manufacturing processes from media/buffer preparation through fill/finish and packaging.

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/GED
• 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

• Strong operational accuracy and attention to detail
• Ability to work in a 12-hour shift schedule
• Good mechanical aptitude

Education

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

Additional Requirements

• Location: Elwood, KS (Onsite)