Bio Manufacturing Operator

Role Summary

An operator is responsible for performing and documenting all tasks and activities associated with biologics manufacturing at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility.

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 aseptic technique and attention to sterile environments.
• Process monitoring and documentation.

Education

• Associate or Bachelor‚Äôs degree in a biomanufacturing related discipline (eg. biology, chemistry, engineering, etc.)

Additional Requirements

• Location: Elwood, KS (Onsite).