Sr. Scientist
healthcare
Sr.ScientistTS/MSDigitalPlant
“Sr. Scientist - TS/MS Digital Plant at Sr. Scientist. Skills: digital solutions, models, data systems, process monitoring tools, material tracking models, batch genealogy, release processes, continuous manufacturing, digital solutions for process monitoring, data analysis, control strategy, MES, DeltaV, batch record analytics platforms, integration of batch data products, analytical/parametric data management solutions, cGMP environment, model lifecycle management, business processes for the use”
Industry & Context.
Demonstrated analytical, statistical, and problem-solving skills applicable to manufacturing science; problem-solving capabilities
initial training period of at least 6 months at the Eli Lilly Kinsale, Ireland facility before transitioning to full-time work at the LP1 site in Lebanon, IN
What They're Looking For.
Must Have
PhD in Chemistry (Organic, Synthetic, Medicinal, or Analytical) or B.S. in a related scientific or engineering discipline with at least 3 years of pharmaceutical manufacturing experience, Qualified applicants must be authorized to work in the United States on a full-time basis
Nice to Have
Demonstrated analytical, statistical, and problem-solving skills applicable to manufacturing science, Experience building and maintaining models (e.g., chemometric, material tracking, or process models) in a cGMP manufacturing environment, collaborative skills with the ability to work effectively in cross-functional team environments, Demonstrated verbal and written communication skills, including the ability to facilitate technical discussions with senior stakeholders, Prior experience with continuous manufacturing processes, including process monitoring and control strategy development, Proficiency in data analysis, visualization, and statistical tools (e.g., Python, R, SIMCA, JMP), Familiarity with manufacturing control systems (MES, DeltaV) and batch record/data integration workflows, Experience with troubleshooting, investigation, root cause analysis, and risk assessment in a cGMP environment, Prior work with cross-functional teams spanning Quality, Manufacturing, Engineering, IT/Automation, and Validation
What You'll Do.
and maintain material tracking models using mathematical and first-principles approaches to support batch genealogy and release processes in continuous manufacturing
Design and execute digital solutions for process monitoring
and control strategy across MES
and batch record analytics platforms
Lead integration of batch data products and analytical/parametric data management solutions using appropriate tools (e.g.
R) within a cGMP environment
Own model lifecycle management including documentation
verification protocols
ongoing monitoring plans
and training for model users to ensure models remain in a verified state and data integrity is maintained
Develop and implement business processes for the use of models and digital solutions in manufacturing
partnering with QA and Operations to ensure compliance
Build technical expertise in continuous manufacturing digital systems and demonstrate data-driven decision-making and problem-solving capabilities
How You'll Work.
Team & Collaboration
Collaborate cross-functionally with process scientists, process Engineering, QA, IT/Automation, operations, and development to identify, build, and validate digital tools that support a robust control strategy; partnering with QA and Operations to ensure compliance; partner with Development Scientists, Engineering, Operations, Materials Management, Quality & Regulatory, and IT/Automation to develop and implement digital solutions supporting a robust control strategy
Communication Scope
Demonstrated verbal and written communication skills; ability to facilitate technical discussions with senior stakeholders
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