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.

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 (Required)
• Proficient in basic computer skills (Windows/Microsoft Office) and communication (written & verbal) (Required)
• Demonstrates teamwork, initiative, a strong work ethic, and a positive attitude (Required)
• Must be able to wear appropriate gowning and personal protective equipment (PPE) in production and manufacturing support areas (Required)
• Associate or Bachelor's degree in a biomanufacturing related discipline (Preferred)
• Experience in a regulated, commercial GMP biomanufacturing environment (Preferred)
• Understanding of USDA, FDA, and EU GMP regulatory standards for veterinary biologics (Preferred)
• Good mechanical aptitude (Preferred)

Skills

• Process execution and documentation
• Regulatory compliance (cGMP, USDA/FDA/EMA)
• Aseptic technique and sterile environment management
• Equipment operation and maintenance
• Quality control interfacing and environmental monitoring

Education

• High School Diploma or GED (Required)
• Biomanufacturing related degree (Associate/Bachelor's) (Preferred)

Additional Requirements

• Location: Elwood, KS (Onsite)
• Shift: 12-hour schedule (5:00 AM to 5:15 PM) with every other weekend; weekend work may include premium pay