Sr./Principle Scientist - TSMS Small Molecule External Manufacturing
Eli Lilly and Company
9 hours ago
On-site
Indianapolis, IN
Operations
Job Description
API EM TS/MS Sr. Principle Scientist will provide technical and scientific expertise within an external manufacturing environment, focused on delivering commercialization efforts for the Small Molecule portfolio (including technical transfers, process validations, and process optimization).
Key Objectives/Deliverables
- Provide technical oversight and stewardship for Small Molecule manufacturing processes.
- Lead resolution of technical issues (e.g., control strategy and manufacturing).
- Use excellent communication skills to manage internal and external relationships.
- Build and maintain relationships with development and central technical organizations.
- Ensure proper characterization of processes and products; document process description, measures, acceptable ranges, specifications, and justification.
- Ensure processes are compliant, capable, in control, and maintained in a validated or qualified state.
- Optimize and execute site control strategies.
- Deliver on strategic initiatives.
- Influence and implement the network technical agenda and drive continuous improvement.
- Maintain processes in a state of compliance with US and global regulations.
- Apply scientific principles for manufacturing drug substances (interaction of chemistry and equipment).
- Coach and mentor peers and other scientists.
Basic Requirements
- Master’s degree or higher in Chemistry or related scientific fields; 8+ years industry experience.
- Experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.
- Must be authorized to work in the United States full-time; Lilly will not sponsor work authorization/visas.
Additional Information
- Occasional travel: 5–15%.
- Location: Onsite in Indianapolis, US.
API EM TS/MS Sr. Principle Scientist will provide technical and scientific expertise within an external manufacturing environment, focused on delivering commercialization efforts for the Small Molecule portfolio (including technical transfers, process validations, and process optimization).
Key Objectives/Deliverables
- Provide technical oversight and stewardship for Small Molecule manufacturing processes.
- Lead resolution of technical issues (e.g., control strategy and manufacturing).
- Use excellent communication skills to manage internal and external relationships.
- Build and maintain relationships with development and central technical organizations.
- Ensure proper characterization of processes and products; document process description, measures, acceptable ranges, specifications, and justification.
- Ensure processes are compliant, capable, in control, and maintained in a validated or qualified state.
- Optimize and execute site control strategies.
- Deliver on strategic initiatives.
- Influence and implement the network technical agenda and drive continuous improvement.
- Maintain processes in a state of compliance with US and global regulations.
- Apply scientific principles for manufacturing drug substances (interaction of chemistry and equipment).
- Coach and mentor peers and other scientists.
Basic Requirements
- Master’s degree or higher in Chemistry or related scientific fields; 8+ years industry experience.
- Experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.
- Must be authorized to work in the United States full-time; Lilly will not sponsor work authorization/visas.
Additional Information
- Occasional travel: 5–15%.
- Location: Onsite in Indianapolis, US.