Manufacturing Scientist - Pilot Scale, Technical Services Manufacturing Science (Transportation)
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 Technical Services & Manufacturing Science (TSMS) Scientist is responsible for providing technical support for commercial and pilot laboratory operations 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, troubleshooting and continuous improvement activities.
- Work with Manufacturing, Development and Quality teams in execution of technical / development studies, investigations, validation activities and technical transfer programs.
- Collaborate with team members to identify potential risks, sources of variability, improvement, and value engineering opportunities to maximize project return and likelihood of technical success.
- Use scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes are capable and operating in a state of control, and identify opportunities for process improvements.
- Participate in design, development, execution, commissioning, qualification, and validation activities for major projects. This includes, but is not limited to; definition of project scope, development and analysis of design options, establishment of user requirements, selection of appropriate equipment, support of commissioning and qualification programs, design and execution of cleaning validation / process validation activities, etc.
- Author and provide critical review of technical documents including, but not limited to, batch records, SOPs, PFDs, risk assessments, investigations, technical studies, commissioning and qualification protocols and reports.
Minimum Qualifications:
- Bachelor's degree or equivalent experience in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline.
- 3+ years' experience in the Biotech / Pharmaceutical industry.
- Detailed understanding of biopharmaceutical production processes and technologies with working knowledge of cGMP standards and experience working in a regulated environment.
Preferred Qualifications:
- MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline.
- 5+ years' experience in the Biotech / Pharmaceutical industry.
- Demonstrated experience in commercial monoclonal antibody / recombinant protein manufacturing processes.
- Experience in tech transfer, scale up, and validation of biopharmaceutical processes.
- Experience in capital project design, development, validation and execution.
Additional Information:
- Day shift position. Weekend and evening work not usual, although may be required to provide process support to ongoing operations.
- Minimal travel requirements < 10%.
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
