Your Role: TSMS Scientist- Pilot Laboratory

The Technical Services & Manufacturing Science (TSMS) Sr. 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. 

Your Responsibilities:  

• 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.

What You Need to Succeed (minimum qualifications): 

• Bachelor's degree or equivalent 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.

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 in capital project design, development, validation and execution.

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 underrecognized 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 weeklong shutdowns (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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