TSMS Scientist (Secondary Loop)

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 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 Role:

Technical Ownership of Product and Process

• Provide technical and on-floor 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, validation activities and technical transfer programs.
• Provide on-floor support to the Manufacturing teams regarding product and process troubleshooting.  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.
• Act as product and process subject matter expert in Process Teams, project teams and committees. 
• 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.
• Develop / execute projects to address process performance issues and deliver on improvement opportunities.
• 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 operational teams.
• 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 and equipment.
• Demonstrate strict adherence to relevant local, state and federal requirements, cGMP standards and Elanco policies and procedures. Exemplify “Safety First and Quality Always” mind-set.

Building 2 Operations:

• Performs cell expansion procedures and ancillary functions to assist with upstream processing of biopharmaceutical products including media and/or buffer formulation and preparation, cell expansion, filtration, and titer analysis.
• Design and conduct experiments for the development or optimization of downstream purification processes, applying proven understanding in filtration technologies, column chromatography, ultracentrifugation, and scale-up principles.
• Maintains and troubleshoots general laboratory equipment including incubators, bioreactor systems, chromatography skids, TFF systems and other ancillary equipment.
• Prepares DOE experimental plans, data summaries, reports and process descriptions for process development / optimization activities.
• Collaborate with cross functional teams (including technology development and manufacturing) on data and experimental design, prepare documents and experiments, participate in investigations, and optimize purification methods.
• Maintains detailed and accurate records by logging equipment usage, procedures and results in logbooks, Batch Records, or laboratory notebooks in accordance with GDPs.

What You Need to Succeed (minimum qualifications):

• Education: Bachelor’s degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
• Required Experience: 3+ years’ experience in the Biotech / Pharmaceutical industry. Detailed understanding of biopharmaceutical production processes and technologies. 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.
• Experience in tech transfer, scale up, and validation of biopharmaceutical processes.
• Experience with SAP, JMP, Veeva Vault.
• Excellent technical writing skills.
• Understanding and application of RCI, FMEA and QRM tools.
• Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.

Additional Information:

• Location: Elwood, KS (onsite)
• Shift: Day shift position. Weekend and evening work not usual, although may be required to provide process support to ongoing operations.
• Travel: Minimal 10%.

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: 

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