Responsibilities
- Scientist β TSMS PAR focuses on delivery of parenteral operations: technical transfer and process validation.
- Support formulation, filling, or visual inspection (VI); may support multiple areas during start-up.
- Maintain validated state of applicable processes; establish/monitor statistically based metrics/methods for capability and control.
- Harmonize control strategies across process teams; evaluate process improvement and serve as escalation point for day-to-day operations issues.
- Author and execute protocols; conduct root cause investigations.
- Provide technical leadership for Parenteral Process Team; mentor within TSMS team; engage in upstream/external activities related to parenteral manufacturing.
Key Objectives/Deliverables
- Support assigned process team (formulation, filling, or VI) as TSMS representative.
- Serve as floor-level support and technical interface for manufacturing components, equipment, and operations.
- Lead risk management activities (product/process).
- Support non-routine investigations (deviations, complaints) including consultation on quality/stability.
- Prepare and review/approve technical documents (Annual Product Reviews, Change Controls, Regulatory Submissions, Deviations, Validations, Procedures, PFDs, PFMEAs, etc.).
- Identify and lead technical projects to improve process control/productivity; drive stability strategy.
- Interface with upstream suppliers and parenteral product networks; provide audit support as needed.
Basic Qualifications
- Bachelorβs degree or higher in engineering, science, or related field.
- Must be authorized to work in the U.S. full-time; Lilly does not sponsor visas/work authorization.
Additional Skills/Preferences
- Pharmaceutical and/or medical device manufacturing experience.
- Root cause investigation experience.
- Proficiency: Microsoft Office, Veeva Vault, TrackWise, electronic batch records, SAP.
- Demonstrated cross-functional leadership; strong interpersonal/teamwork; strong self-management/organizational skills.