Supervisor, Manufacturing (Fill / Finish) at Elanco in Elwood, Kansas

Job Description:

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

The Supervisor, Manufacturing (Fill / Finish) is responsible for leading personnel, tasks and activities associated with aseptic filling and finishing of sterile injectables at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility.  The candidate has a demonstrated breadth and depth of skills across aseptic filling, finishing and secondary packaging operations.  The supervisor is accountable for scheduling and managing day to day operations, has oversight of the production floor processes, and coordinates the work of others.  The supervisor is responsible for ensuring departmental goals are met, including delivering on production targets while maintaining compliance with Quality, Safety, and Good Manufacturing Practice standards.

Your Responsibilities:

Manufacturing Operations

• Execute and monitor critical processes for mAb manufacturing related to filling, finishing, and packaging to a defined production schedule, following cGMP guidelines, Standard Operating Procedures (SOPs) and applicable regulatory requirements.


• Operate in a USDA/EMA cGMP regulated environment, maintaining strict adherence to all applicable regulations and ensure manufacturing team consistently operates in a state of compliance.


• Drive and model behaviors in alignment with company principles with a particular emphasis on speaking up for safety and quality.


• Maintain consistent shop floor presence to ensure performance, reinforce behaviors, and drive continuous improvement of the fill / finish manufacturing team.


• Accurately follow and enforce adherence to SOPs 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 is maintained per approved procedures, and that batch documentation reviews are completed in a timely manner.


• Ensure timely completion of SAP entries including material management and production execution transactions.


• Author, review, and/or approve SOPs, protocols, batch records, data summaries and reports.


• Provide input into development of production schedule and ensure adherence to it.


• Support Maintenance and Engineering personnel as necessary with equipment maintenance and calibration.


• Partner with process teams to identify and implement process optimization solutions, ensuring adherence to change management procedures.


• Escalate significant issues and potential solutions to line management.


• Build and grow the fill / finish team, recruiting and developing talent in alignment with the site’s strategic needs.


• Develop and review operational objectives with direct reports, establish appropriate talent development plans, and conduct staff performance management reviews as required.


• Ensure all fill / finish staff are properly trained for their roles and operate in adherence with corporate and regulatory standards.


• Act as a change agent and influences others to understand, support, and drive improvements.

Report Issues and Solve Problems

• Recognize and solve typical problems that can occur in own work unit.


• Track and evaluate in-process data to minimize manufacturing variability.


• Report issues and events such as quality deviations, injuries/illnesses, etc.


• Assist in improving safe working conditions by identifying / resolving hazards.


• Troubleshoot equipment and process issues.


• Assist in performing investigations for issues and events.

Minimum Qualifications:

• High School Diploma or equivalent.


• 3+ years’ experience in a regulated, commercial GMP biomanufacturing environment (relevant experience may include: aseptic processing, final formulation, fill / finish, secondary packaging).


• Strong technical / equipment knowledge and troubleshooting 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.


• 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.

Additional Preferences:

• AS or Bachelor’s degree (or equivalent) in a biomanufacturing related discipline (eg. biology, chemistry, engineering, etc.).


• Demonstrated success in leading operational teams.


• Understanding of USDA, FDA, and EU GMP regulatory standards for veterinary biologics.


• Strong problem-solving skills, and experience performing / leading root cause investigations.


• 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.


• Ability to use IT tools such as OSI PI, Veeva, CMMS (SAP).


• Basic computer skills including experience with Windows Operating System and Microsoft Office products. 

Other Information:

• Location: Elwood, KS. This is considered an on-site position.


• Shift: Day (1st).This position may require occasional overtime.


• Performs all Company business in accordance with all regulations (e.g. USDA, EMA, OSHA, etc.) and Company policy and procedures.

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