Technical Services Manufacturing Scientist (Night Shift)
Elanco
Full-time
On-site
Elwood, KS
Operations
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Role Summary
Technical Services Manufacturing Scientist (Night Shift) at Elwood, Kansas; provides technical support for commercial monoclonal antibody manufacturing, serves as subject matter expert, and leads tech transfer, scale-up, validation, and continuous improvement activities.
Responsibilities
- Provide technical and on-floor support for the commercialization, manufacture, and life-cycle management of monoclonal antibody products, including troubleshooting and root-cause analyses of deviations, complaints, and OOS/OOE events.
- Act as product and process subject matter expert in Process Teams, project teams, and committees.
- Use scientific and statistical analysis tools to improve process understanding, ensure processes are in control, and identify opportunities for improvement.
- Develop and execute projects to address process performance issues and deliver improvements.
- Author and review technical documents including batch records, SOPs, PFDs, risk assessments, investigations, technical studies, protocols, and reports.
Qualifications
- Required: Bachelor’s degree (or equivalent) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or related discipline; experience in the Biotech/Pharmaceutical industry; understanding of biopharmaceutical production processes and technologies; working knowledge of cGMP in a regulated environment; proven analytical thinking and problem-solving skills.
- Preferred: MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering, or related discipline; experience in commercial monoclonal antibody/recombinant protein manufacturing; experience in tech transfer, scale-up, and validation; proficiency with SAP, JMP, Veeva Vault, RCI, FMEA, and QRM tools; knowledge of USDA and/or EU GMP regulations for veterinary biologics.
Skills
- Technical troubleshooting
- Process optimization and improvement
- Technical documentation and critical review
- Statistical analysis and problem solving
- Cross-functional collaboration
Education
- Bachelor’s degree required; advanced degrees preferred in relevant fields
Additional Requirements
- Location: Elwood, Kansas
- Night shift with weekend work on a rotation to support ongoing operations