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!
The Operator is responsible for performing and documenting all tasks and activities associated with biologics manufacturing at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. The position will be expected to demonstrate a high level of initiative and ownership. Departmental goals include meeting quality and quantity production targets while maintaining compliance with Safety and Good Manufacturing Practice standards.
Functions, Duties, Tasks:
- 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.
- Ensure the completeness and accuracy of manufacturing documentation per approved procedures.
- 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, and ancillary equipment.
- Assist Maintenance and Engineering personnel as necessary with equipment maintenance and calibration.
- Identify and support the implementation of process improvement opportunities where applicable.
- Draft and review standard operating procedures (SOP’s), protocols, batch records, data summaries and reports.
- Perform work safely, to Elanco quality standards, and maintain a safe, clean work environment.
- Other duties as assigned.
Report Issues and Solve Problems
- Report issues and events such as injuries/illnesses, quality deviations, etc.
- Assist in improving safe working conditions by identifying / resolving hazards.
- Assist in performing investigations for issues and events.
- Troubleshoot equipment and process issues.
Basic Minimum Qualifications:
- High School Diploma or equivalent.
- Basic computer skills including experience with Windows Operating System and Microsoft Office products.
- Proficient reading, comprehension, and application skills toward a diverse set of complicated tasks.
- Ability to accurately perform calculation, analyze, and processes scientific data.
- Demonstrated success working in a team environment.
- 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.
- Bachelor’s degree (or equivalent) in a biomanufacturing related discipline (eg. biology, chemistry, engineering, etc.).
- 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).
- Understanding of USDA, FDA, and EU GMP regulatory standards for veterinary biologics.
- Strong verbal and written communication skills.
- Must be highly motivated, follow oral and written instructions, communicate effectively, think logically, and thrive independently and/or in a fast-paced team environment.
- Innovative spirit, strong initiative and work ethic, and positive attitude.
- Able to follow written instructions and provide detailed documentation of work performed
- 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
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