Senior Scientist - TSMS

Role Summary

Senior Scientist - TSMS at Lilly, providing technical and scientific expertise within a dynamic external manufacturing environment to achieve reliable and compliant manufacture of API drug substance at external contract manufacturing groups to global quality standards. The role involves process monitoring, issue response, and improvements, with cross-functional collaboration to deliver technical objectives.

Responsibilities

• Provide technical oversight and stewardship for peptide manufacturing processes.
• Lead resolution of technical issues including control strategy and manufacturing.
• Manage internal and external relationships through excellent communication.
• Build and maintain relationships with development and central technical organizations.
• Ensure proper characterization of processes and products and document process descriptions, measures, acceptable ranges, and specifications.
• Ensure processes are compliant, capable, in control, and maintained in a validated or qualified state.
• Justify and document the state of validation with data evaluating process capability.
• Influence and implement the network technical agenda and drive continuous improvement.
• Maintain peptide processes in compliance with US and global regulations.
• Understand scientific principles for manufacturing intermediates and drug substances, including chemistry and equipment interaction.
• Coach and mentor peers and other scientists within Team Lilly.

Qualifications

• Required: Bachelor's in Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Chemistry/Biochemistry strongly preferred).
• Required: 3+ years of demonstrated experience with pharmaceutical manufacturing and knowledge of regulatory expectations.

Skills

• Regulatory knowledge and data management experience across manufacturing.
• Strong communication, collaboration, and cross-functional delivery abilities.
• Project management skills and ability to coordinate complex projects.
• Ability to influence diverse groups on business or technical issues within the site and function.

Education

• Bachelors in a scientific discipline as listed above (Chemistry/Biochemistry preferred).

Additional Requirements

• Some travel may be required.
• Some off-shift work (night/weekend) may be required to support 24/7 operations.