Technical Services & Manufacturing Science (TSMS) Scientist - Nights
Elanco
19 days 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 real-time troubleshooting and participate in investigations (root cause analysis of deviations, complaints, and OOS/OOE). Ensure proper documentation, CAPA development, and resolution within quality systems.
- Serve as a subject matter expert for product and process within cross-functional teams 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 addressing process performance issues and driving measurable improvements.
- Support resolution of technical and compliance-related issues, including preparing technical assessments and responses for internal audits and regulatory agencies.
Qualifications:
- Bachelor’s degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or related discipline.
- Working knowledge of biopharmaceutical production processes/technologies and experience in a cGMP-regulated environment.
- Strong analytical/problem-solving skills; ability to troubleshoot technically and collaborate across cross-functional teams.
Preferred qualifications:
- MSc/PhD in a related discipline; 3+ years biotech/pharma experience.
- Experience with monoclonal antibody or recombinant protein manufacturing; tech transfer, scale-up, and validation.
- Familiarity with SAP, JMP, and Veeva Vault; technical writing; RCI, FMEA, QRM.
- Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.
Location/Shift:
- Elwood, Kansas; night shift with weekend/evening rotation; minimal travel.
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 real-time troubleshooting and participate in investigations (root cause analysis of deviations, complaints, and OOS/OOE). Ensure proper documentation, CAPA development, and resolution within quality systems.
- Serve as a subject matter expert for product and process within cross-functional teams 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 addressing process performance issues and driving measurable improvements.
- Support resolution of technical and compliance-related issues, including preparing technical assessments and responses for internal audits and regulatory agencies.
Qualifications:
- Bachelor’s degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or related discipline.
- Working knowledge of biopharmaceutical production processes/technologies and experience in a cGMP-regulated environment.
- Strong analytical/problem-solving skills; ability to troubleshoot technically and collaborate across cross-functional teams.
Preferred qualifications:
- MSc/PhD in a related discipline; 3+ years biotech/pharma experience.
- Experience with monoclonal antibody or recombinant protein manufacturing; tech transfer, scale-up, and validation.
- Familiarity with SAP, JMP, and Veeva Vault; technical writing; RCI, FMEA, QRM.
- Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.
Location/Shift:
- Elwood, Kansas; night shift with weekend/evening rotation; minimal travel.