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.
Position Title: Biomanufacturing Operator
Supervisor Title: Sr Director Biomanufacturing and Process Development
Job Level (PLS): B1-2
Position Type: FTE
Job Function: Manufacturing
Location: Elwood, KS
Position Description: Bioprocessing Operator is responsible for performing all tasks and activities associated with biologics manufacturing. The manufacturing operator will be required to demonstrate a high level of initiative and ownership. Departmental goals include meeting quality and quantity targets while maintaining safety and Good Manufacturing Practice compliance.
Basic Minimum Qualifications :
- High School Diploma/GED
- Must be highly motivated, follow oral and written instructions, communicate effectively, think logically, and thrive independently and/or in a fast-paced team environment.
- Must be able to perform aseptic manipulations and show intermediate knowledge and experience of aseptic techniques
- Ability to accurately analyze and processes scientific data
- Must be proficient in Word and Excel.
- Ability to work flexible hours as necessary to meet production demands and timelines.
- Able to follow written instructions and provide detailed documentation of work performed
Functions, Duties, Tasks:
- Execute and monitor critical processes supporting upstream monoclonal antibodies (mAb) expression and downstream purification.
- Work in an USDA / FDA / EMA cGMP regulated environment requiring adherence to all applicable regulations.
- Interface with Quality Control department to submit in-process samples and coordinate environmental monitoring during key process steps.
- Provide support to cross-functional teams to meet production or timeline demands.
- Demonstrate understanding in scientific concepts, technical operations, safety, and Good Manufacturing Practice.
- Accurately follow SOP’s for operating production equipment and performing processing steps
- Assemble, prepare, and maintain process equipment: biological safety cabinets, incubators, bioreactors, chromatography skids, columns, TFF systems, and ancillary equipment.
- Draft and review standard operating procedures (SOP’s), protocols, batch records, slide deck data summaries and reports
- Ability to contribute to the development of new concepts, techniques, and standards
- Assist Facilities and Engineering personnel as necessary on equipment maintenance and calibration
- Identify and support the implementation of process efficiencies and optimization when applicable.
- Ensure the completeness and accuracy of manufacturing documentation per approved procedures
- Associate Degree - Science or Chemical Engineering
- 2 years of experience in GMP production including cell culture, fermentation, media preparation, aseptic processing, chromatography, TFF, final formulation and filling and buffer preparation.
- Ability to interpret process trends and data and react appropriately to unexpected outcomes.
- Innovative spirit, strong initiative and work ethic, and positive attitude.
- Intermediate level knowledge and understanding of 9CFR, 21CFR, European Eudralex, and ICH guidelines
- 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