Senior Scientist - TSMS

About the role

Headquartered in Indianapolis, Indiana, Lilly unites caring with discovery to help make life better for people around the world. The Active Pharmaceutical Ingredient – External Manufacturing Organization (API-EM) delivers a diverse portfolio of medicines essential to patients globally. The API EM TS/MS Sr. Scientist provides technical and scientific expertise within a dynamic external manufacturing environment, ensuring reliable and compliant manufacture of API drug substance at external contract manufacturing groups to predetermined global quality standards. This role involves daily interaction with external partners, team members, and site management, with responsibility for process monitoring, issue resolution, and continuous improvement.

Key Objectives and Deliverables

• Provide technical oversight and stewardship for peptide manufacturing processes.
• Lead resolution of technical issues, including those related to control strategy and manufacturing.
• Employ 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 and effective documentation of process description, measures, acceptable ranges, and specifications (including justification).
• Ensure processes are compliant, capable, in control, and maintained in a validated or qualified state.
• Understand, justify, and document the state of validation with data evaluating process capability to meet its stated purpose.
• Influence and implement the network technical agenda and drive continuous improvement.
• Maintain peptide processes in a state of compliance with US and global regulations.
• Understand the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
• Operate with ‘Team Lilly’ in mind, including coaching and mentoring of peers and other scientists.

Basic Requirements

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

Additional Preferences

• Knowledge and experience with regulatory requirements.
• Knowledge of data management practices across manufacturing.
• Enthusiasm for change, team spirit, and flexibility.
• Ability to influence and communicate to diverse groups on business or technical issues within the site and function.
• Proficiency in delivering complex tasks and/or tasks that are cross-functional.
• Demonstrated project management skills and ability to coordinate complex projects.

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

Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status).