Sr. Scientist - Technical Services & Manufacturing Science, M&Q
About The Position
The Sr. Scientist, Technical Services & Manufacturing Science (TSMS) provides technical support for commercial and pilot laboratory operations at Elanco’s monoclonal antibody manufacturing facility in Elwood, Kansas. The role serves as a subject matter expert for mAb products and processes, supporting technology transfer, scale-up, process optimization, validation, monitoring, troubleshooting, and continuous improvement. The position partners with Manufacturing, Development, Quality, and other cross-functional teams to execute technical studies, investigations, validation, and technology transfer programs. It applies scientific and statistical analysis to strengthen process understanding and control, identifies risks and improvement opportunities, and supports major projects from design and equipment selection through commissioning, qualification, and validation. The role also develops and reviews technical documentation and supports a strong safety, quality, compliance, and continuous improvement culture.
Requirements
- Bachelor’s degree or equivalent in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
- At least 3 years of experience in the Biotechnology or Pharmaceutical industry.
- Detailed understanding of biopharmaceutical production processes and technologies.
- Working knowledge of cGMP standards and experience working in a regulated environment.
- Must be legally authorized to be employed in the United States; the employer does not anticipate providing employment visa sponsorship.
Nice To Haves
- MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
- At least 5 years of experience in the Biotechnology or Pharmaceutical industry.
- Demonstrated experience with commercial monoclonal antibody or recombinant protein manufacturing processes.
- Experience in technology transfer, scale-up, and validation of biopharmaceutical processes.
- Experience with capital project design, development, validation, and execution.
- Strong scientific and statistical analysis capabilities.
- Experience identifying process variability, technical risks, and continuous improvement opportunities.
Responsibilities
- Partner with Manufacturing, Development, and Quality teams to execute technical and development studies, investigations, validation activities, and technical transfer programs.
- Collaborate with cross-functional teams to identify risks, sources of variability, improvement opportunities, and value engineering opportunities.
- Apply scientific and statistical analysis tools to improve process understanding, maintain capable and controlled manufacturing processes, and identify process improvement opportunities.
- Participate in the design, development, execution, commissioning, qualification, and validation of major projects.
- Support project scope definition, design-option development and analysis, user requirements, equipment selection, commissioning, and qualification activities.
- Design and execute cleaning validation and process validation activities.
- Author and critically review technical documentation, including batch records, SOPs, PFDs, risk assessments, investigations, technical studies, and commissioning and qualification protocols and reports.
- Support a strong safety, quality, compliance, and continuous improvement culture within the manufacturing organization.
Benefits
- Multiple relocation packages
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Flexible work arrangements
- Up to 6% 401(k) matching
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What This Job Offers
Job Type
Full-time
Career Level
Senior
