Sr. Scientist - Technical Services & Manufacturing Science, M&Q
Elanco
Summary
As the Technical Services & Manufacturing Science (TSMS) Sr. Scientist, you'll provide technical support for commercial and pilot laboratory operations at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. In this role, you'll serve as a subject matter expert for mAb products and processes, supporting tech transfer, scale-up, process optimization, validation, monitoring, troubleshooting, and continuous improvement activities.
Job description
Your 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 to maximize project return and technical success.
- Apply scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes remain capable and in a state of control, and identify opportunities for process improvement.
- Participate in the design, development, execution, commissioning, qualification, and validation of major projects.
- Support project scope definition, development and analysis of design options, establishment of user requirements, equipment selection, and commissioning and qualification activities.
- Design and execute cleaning validation and process validation activities.
- Author and provide critical review of 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.
What You Need to Succeed (minimum qualifications)
- Bachelor's degree or equivalent in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
- 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.
What Will Give You a Competitive Edge (preferred qualifications)
- MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
- 5+ years of experience in the Biotechnology or Pharmaceutical industry.
- Demonstrated experience with commercial monoclonal antibody or recombinant protein manufacturing processes.
- Experience in tech 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.
Requirements
- Bachelor's degree or equivalent in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline
- 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
- Legally authorized to be employed in the United States
Benefits
- Relocation Packages
- 8-Week Parental Leave
- Employee Resource Groups
- Annual Bonus
- Flexible Work Arrangements
- 401(k) Matching
Company overview
Elanco Animal Health Incorporated is a global leader in the animal health pharmaceutical industry, dedicated to improving the health and well-being of both pets and farm animals worldwide. Founded in 1954 as a division of Eli Lilly and Company, Elanco became an independent public company in 2018 and has since grown to become the world's second-largest independent animal health company. With approximately 9,000 employees globally, the company operates with a clear purpose: 'making life better for animals, makes life better.' Elanco develops innovative medicines, vaccines, and health solutions that empower veterinarians, farmers, and pet owners to advance animal care. The company maintains a balanced portfolio between pet health and farm animal products, offering over 200 brands that address critical health challenges ranging from companion animal diseases to livestock productivity. Headquartered in Indianapolis, Indiana, Elanco is publicly traded on the New York Stock Exchange (NYSE: ELAN) and continues to drive innovation in animal health through strategic acquisitions and dedicated research and development efforts.