Technical Services Manufacturing Scientist (Day Shift)

About the role

The Technical Services & Manufacturing Science (TS/MS) Scientist at Elanco is responsible for providing technical and on-floor support for the commercialization, manufacture, and life-cycle management of monoclonal antibody products. This includes troubleshooting, participating in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events. The position involves acting as the Process Team's product and process subject matter expert for purification processes which may include chromatography, tangential flow filtration, and centrifugation. The TSMS scientist also uses 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. They develop and execute projects to address process performance issues and deliver improvement opportunities. Additionally, they author and provide critical reviews of technical documents including, but not limited to, batch records, SOPs, PFDs, process recipes, risk assessments, investigations, technical studies, protocols, and reports.

Responsibilities

• Provide technical and on-floor support for the commercialization, manufacture, and life-cycle management of monoclonal antibody products.
• Participate in troubleshooting, product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events.
• Act as the Process Team's 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 and execute projects to address process performance issues and deliver improvement opportunities.
• Author and provide critical reviews of technical documents including, but not limited to, batch records, SOPs, PFDs, process recipes, risk assessments, investigations, technical studies, protocols, and reports.

Requirements

• 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.

Preferred Qualifications

• 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.

Additional Information

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

Elanco Benefits and Perks

• 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.
• Up to 6% 401K matching.
• Annual bonus offering.
• Elanco Workforce Privacy Notice.