Bio Manufacturing Operator

About the role

The Elanco Elwood, Kansas facility, acquired from Kindred Biosciences in 2021, offers a strong pipeline of innovative drugs for companion animals within the monoclonal antibody space. This role involves executing and monitoring core mAb manufacturing processes and maintaining cGMP compliance in a regulated 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.

Requirements

• Education: High School Diploma or equivalent.
• Proficient in basic computer skills (Windows/Microsoft Office) and communication (written & verbal).
• Must be able to wear appropriate gowning and personal protective equipment (PPE) in production and manufacturing support areas.

Preferred Qualifications

• Associate or Bachelor's degree in a biomanufacturing related discipline (eg. biology, chemistry, engineering, etc.).
• 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).
• Understanding of USDA, FDA, and EU GMP regulatory standards for veterinary biologics.
• Good mechanical aptitude.

What Will Give You a Competitive Edge

• Associate or Bachelor's degree in a biomanufacturing related discipline (eg. biology, chemistry, engineering, etc.).
• 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).
• Understanding of USDA, FDA, and EU GMP regulatory standards for veterinary biologics.
• Good mechanical aptitude.

Additional Information

• Location: Elwood, KS (Onsite).
• Elanco Benefits and Perks: Comprehensive benefits package focusing on financial, physical, and mental well-being.
• Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.