Bio Manufacturing Operator

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

$2,500 sign-on bonus eligible!

Why Work at Elwood?

The Elanco Elwood, Kansas facility was acquired from Kindred Biosciences in 2021 which offers a strong pipeline of innovative drugs for companion animals within the monoclonal antibody space. Working at a monoclonal antibody start-up facility in Elwood, Kansas presents an exciting opportunity to contribute to cutting-edge research: Monoclonal antibodies are an innovative type of biologic drug that can target specific molecules in the body to treat a variety of diseases, including cancer and autoimmune disorders. Working at a start-up facility that is developing these drugs is an opportunity to be on the forefront of medical research and contribute to developing treatments that can have a significant impact on pets' lives.

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 critical processes for mAb manufacture such as media and buffer preparation, upstream expression, downstream purification, formulation, fill/finish, and/or secondary packaging.
• Operate in a USDA / FDA / EMA cGMP regulated environment, maintaining strict adherence to all applicable regulations.
• Accurately follow SOP’s and batch production records in operation of production equipment, performance of processing steps, and execution of daily tasks.
• Perform aseptic manipulations and demonstrate knowledge and experience of aseptic techniques.
• Interface with the Quality Control department to submit in-process samples and coordinate environmental monitoring during key process steps.
• Assemble, prepare, and maintain process equipment including, but not limited to biological safety cabinets, incubators, bioreactors, chromatography skids, columns, tangential flow filtration systems, pumps, fill/finish units, labelling/packaging units and ancillary equipment.
• Identify and support the implementation of process improvement opportunities where applicable.
• Perform work safely, to Elanco quality standards, and maintain a safe, clean work environment.

Minimum Qualifications:

• High School Diploma or equivalent.
• Basic computer skills including experience with Windows Operating System and Microsoft Office products.
• Strong verbal and written communication skills
• Proficient reading, comprehension, and application skills toward a diverse set of complicated tasks.
• Ability to accurately perform calculations, analyze, and processes scientific data.
• Demonstrated success working in a team environment.
• Innovative spirit, strong initiative and work ethic, and positive attitude.
• Demonstrated ability and understanding of safe working habits.
• Ability to work flexible hours as necessary to meet production demands and timelines.
• Must be able to wear appropriate gowning and personal protective equipment (PPE) in production and manufacturing support areas.
• Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Additional Preferences:

• Bachelor’s degree (or equivalent) 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.

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