TSMS Scientist (Secondary Loop) - Elanco
Elwood, KS 66024
About the Job
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: TSMS Scientist (Secondary Loop)
The Technical Services & Manufacturing Science (TSMS) Scientist is responsible for providing technical support for commercial 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. The TSMS scientist plays a key role in day-to-day operations and delivery of technical projects.
Your Responsibilities: Technical Ownership of Product & Process
- Provide technical support for the commercialization, manufacture, and life-cycle management of monoclonal antibody products. Work with R&D, Manufacturing, and Quality teams in execution of technical / development studies, process improvements, validation activities and technical transfer programs.
- Provide support to the Manufacturing teams regarding product and process troubleshooting and mentoring. 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.
- 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. Provide support in resolution of technical and compliance issues. Prepare technical assessments and responses for site quality, internal inspection bodies, and relevant Health Authorities.
- Author and provide critical review of technical documents including, but not limited to; batch records, SOPs, PFDs, risk assessments, investigations, technical studies, protocols, and reports. Establish and deliver training / coaching on core processes and technologies to cross functional teams.
- Ensure process operations comply with all health, safety, and environmental policies and procedures. Participate in supporting Hazard and Operability (Haz-ops) studies and process safety reviews and identify / mitigate hazards of manufacturing processes and equipment.
What You Need to Succeed (minimum qualifications):
- Education: Bachelor’s degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
- Experience: 3+ years’ experience in the Biotech / Pharmaceutical industry.
- Detailed understanding of biopharmaceutical production processes, technologies, analytical thinking and problem-solving skills.
- Working knowledge of cGMP standards and experience working in a regulated environment.
What will give you a competitive edge (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, tech transfer, scale up, and validation of biopharmaceutical processes.
- Experience with SAP, JMP, Veeva Vault.
- Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.
Additional Information:
- Location: Elwood, Kansas
- Day shift position. Weekend and evening work not usual, although may be required to provide process support to ongoing operations.
- Minimal travel requirements < 10%
Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages
Two weeklongshutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
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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