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)
Responsibilities
- Provide technical and on-floor support for the commercialization, manufacture, and life-cycle management of monoclonal antibody products. This includes troubleshooting, participate in product and process related technical investigations and root-cause analyses of process 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 manufacturing processes are capable and operating in a state of control, and identify opportunities for process improvements.
- Develop / execute projects to address process performance issues and deliver improvement opportunities.
- Author and provide critical review of technical documents including, but not limited to; batch records, SOPs, PFDs, risk assessments, investigations, technical studies, protocols, and reports.
Qualifications
- Required: Bachelor’s degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
- Required: Experience in the Biotech / Pharmaceutical industry.
- Required: 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: MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline.
- Preferred: Demonstrated experience in commercial monoclonal antibody / recombinant protein manufacturing processes.
- Preferred: Experience in tech transfer, scale up, and validation of biopharmaceutical processes.
- Preferred: Experience with SAP, JMP, Veeva Vault, RCI, FMEA and QRM tools.
- Preferred: Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.
Skills
- Technical proficiency in biopharmaceutical production processes
- Analytical thinking and problem-solving
- Project management and cross-functional collaboration
- Technical writing and document review
Education
- Bachelor’s degree required; advanced degrees preferred
Additional Requirements
- Location: Elwood, Kansas.
- Night shift position with weekend rotation to support ongoing operations.