Fill/Finish Scientist- Technical Services Manufacturing Scientist

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!

Your Role: Fill/Finish Scientist- Technical Services Manufacturing Scientist

 

The Technical Services & Manufacturing Science (TSMS) Scientist is responsible for providing Primary and/or Secondary loop technical support for commercial operations, specifically for primary and secondary packaging, at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility.

The position is a subject matter expert with respect to mAb products and processes and is engaged in tech transfer, scale-up, process optimization, validation, monitoring, aseptic fill/finish, troubleshooting and continuous improvement activities.

The TSMS scientist plays a key role in day-to-day operations and delivery of technical projects, relating to primary and secondary packaging.

 

Your Responsibilities:  Technical Ownership of Product and Process


* Provide technical and on-floor support for commercialization, manufacture, media filling simulation, and life-cycle management of monoclonal antibody products, provide on-floor support to the Manufacturing fill/finish teams regarding product and process troubleshooting, and provide support in resolution of technical and compliance issues.

Prepare technical assessments and responses for site quality, internal inspection bodies, and relevant Health Authorities.


* Work with R&D, Manufacturing, and Quality teams in execution of technical / development studies, validation activities and technical transfer programs for fill/finish and participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events.


* Ensure issues are identified and captured in the relevant quality management system and that proper root cause analysis is performed with appropriate corrective and preventative actions
assigned and ensure process operations comply with all health, safety, and environmental policies and procedures.

Participate in Hazard and Operability (Haz-ops) studies and process safety reviews and identify / mitigate hazards of manufacturing processes a...