Technical Services Manufacturing Scientist - Downstream

Your Role

The Technical Services & Manufacturing Science (TS/MS) Scientist is responsible for providing Primary and/or Secondary loop technical support for commercial downstream 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.

• Provide technical and on-floor support for the commercialization, manufacture, and life-cycle management of monoclonal antibody products. This includes troubleshooting, participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events.
• Act as the Process Teams product and process subject matter expert for purification processes which may include chromatography, tangential flow filtration, and centrifugation.
• 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 improvement opportunities.
• Author and provide critical review of technical documents including, but not limited to; batch records, SOPs, PFDs, process recipes, risk assessments, investigations, technical studies, protocols, and reports.

• Education: Bachelor’s degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
• Experience: 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. Proven analytical thinking and problem-solving skills.

• MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline.
• 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, RCI, FMEA and QRM tools.
• Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.

• Location:
  
  Elwood, Kansas.
• Day shift position. Weekend work on a rotation to provide process support to ongoing operations.

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!

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 for eligible roles
• 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
• Up to 6% 401K matching

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.