Technical Services & Manufacturing Science (TSMS) Scientist - Nights
Elanco
5 hours ago
On-site
Elwood, KS
Operations
Technical Services & Manufacturing Science (TSMS) Scientist, Nights
Responsibilities:
- Provide technical and on-floor support for the commercialization, manufacture, and lifecycle management of monoclonal antibody products.
- Collaborate with R&D, Manufacturing, and Quality to execute technical studies, validation activities, and technology transfer programs.
- Support manufacturing teams with real-time troubleshooting; participate in investigations (deviations, complaints, OOS/OOE) including root cause analysis; ensure documentation, CAPA development, and resolution within quality systems.
- Serve as a subject matter expert for product and process in cross-functional teams, projects, and governance forums.
- Use scientific and statistical tools to improve process understanding, maintain process control, and identify optimization/continuous improvement opportunities.
- Lead and execute projects to address process performance issues and drive measurable improvements.
- Support resolution of technical and compliance-related issues, including preparing technical assessments and responses for internal audits and regulatory agencies.
Minimum Qualifications:
- Bachelor’s degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or related.
- Working knowledge of biopharmaceutical production processes/technologies and experience in a cGMP-regulated environment.
- Strong analytical and problem-solving skills; ability to troubleshoot technically and collaborate across cross-functional teams.
Preferred Qualifications:
- MSc or PhD in a related discipline.
- 3+ years biotech/pharmaceutical industry experience.
- Experience with monoclonal antibody or recombinant protein manufacturing.
- Experience with tech transfer, scale-up, and validation of biopharmaceutical processes.
- Familiarity with SAP, JMP, and Veeva Vault.
- Technical writing skills; experience with RCI, FMEA, QRM.
- Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.
Benefits:
- Multiple relocation packages; 8-week parental leave; annual bonus offering; up to 6% 401(k) matching.
Additional Info:
- Location: Elwood, Kansas. Night shift with weekend/evening rotation. Travel: minimal.
Responsibilities:
- Provide technical and on-floor support for the commercialization, manufacture, and lifecycle management of monoclonal antibody products.
- Collaborate with R&D, Manufacturing, and Quality to execute technical studies, validation activities, and technology transfer programs.
- Support manufacturing teams with real-time troubleshooting; participate in investigations (deviations, complaints, OOS/OOE) including root cause analysis; ensure documentation, CAPA development, and resolution within quality systems.
- Serve as a subject matter expert for product and process in cross-functional teams, projects, and governance forums.
- Use scientific and statistical tools to improve process understanding, maintain process control, and identify optimization/continuous improvement opportunities.
- Lead and execute projects to address process performance issues and drive measurable improvements.
- Support resolution of technical and compliance-related issues, including preparing technical assessments and responses for internal audits and regulatory agencies.
Minimum Qualifications:
- Bachelor’s degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or related.
- Working knowledge of biopharmaceutical production processes/technologies and experience in a cGMP-regulated environment.
- Strong analytical and problem-solving skills; ability to troubleshoot technically and collaborate across cross-functional teams.
Preferred Qualifications:
- MSc or PhD in a related discipline.
- 3+ years biotech/pharmaceutical industry experience.
- Experience with monoclonal antibody or recombinant protein manufacturing.
- Experience with tech transfer, scale-up, and validation of biopharmaceutical processes.
- Familiarity with SAP, JMP, and Veeva Vault.
- Technical writing skills; experience with RCI, FMEA, QRM.
- Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.
Benefits:
- Multiple relocation packages; 8-week parental leave; annual bonus offering; up to 6% 401(k) matching.
Additional Info:
- Location: Elwood, Kansas. Night shift with weekend/evening rotation. Travel: minimal.