Sr. Scientist - Technical Services & Manufacturing Science, M&Q
Job in
Elwood, Doniphan County, Kansas, 66024, USA
Listed on 2026-08-29
Listing for:
Elanco Animal Health
Full Time
position Listed on 2026-08-29
Job specializations:
-
Pharmaceutical
Validation Engineer, Quality Engineering, Pharma Engineer -
Engineering
Validation Engineer, Quality Engineering, Pharma Engineer, Process Engineer
Job Description & How to Apply Below
Sr. Scientist - Technical Services & Manufacturing Science, M&Q
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.
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):
- Education:
Bachelor's degree or equivalent in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline. - Experience:
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.
Additional Information:
- Travel:
Minimal travel required (
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