Bio Manufacturing Specialist

6 days ago

Elwood, Kansas, United States Elanco Full time

About Elanco

Elanco is a global leader in animal health, dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. Our vision is to 'Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose – is to advance the health of animals, people, the planet and our enterprise.

Our Culture

We pride ourselves on fostering a diverse and inclusive work environment, where diversity is the driving force behind innovation, creativity, and overall business success. Our team is dynamic, and we value and champion new ways of thinking. We offer a comprehensive benefits package focusing on financial, physical, and mental well-being, while encouraging our employees to pursue our purpose.

Your Role

An operator is responsible for performing and documenting all tasks and activities associated with biologics manufacturing at our facility. Key responsibilities include:

  • Executing and monitoring critical processes for mAb manufacture such as media and buffer preparation, upstream expression, downstream purification, formulation, fill/finish, and/or secondary packaging.
  • Operating in a USDA / FDA / EMA cGMP regulated environment, maintaining strict adherence to all applicable regulations.
  • Accurately following SOP's and batch production records in operation of production equipment, performance of processing steps, and execution of daily tasks.
  • Performing aseptic manipulations and demonstrating knowledge and experience of aseptic techniques.
  • Interfacing with the Quality Control department to submit in-process samples and coordinate environmental monitoring during key process steps.
  • Assembling, preparing, and maintaining 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.
  • Identifying and supporting the implementation of process improvement opportunities where applicable.
  • Performing work safely, to Elanco quality standards, and maintaining a safe, clean work environment.

Requirements

  • Education: 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 process 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.

Preferred Qualifications

  • 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.

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