Senior Scientist - TSMS

Lilly • Indianapolis, IN

3d • $67,500 - $151,800

About The Position

The Senior Scientist - TSMS will provide technical and scientific expertise within Lilly’s Active Pharmaceutical Ingredient - External Manufacturing Organization. The role supports reliable, compliant manufacture of API drug substance at external contract manufacturing groups in accordance with global quality standards. The scientist works closely with external partners and site management, monitors processes, responds to manufacturing issues, and identifies improvements. The work requires knowledge of cGMPs, global regulatory manufacturing guidance, and corporate and industry standards, alongside cross-functional collaboration to meet technical objectives.

The position provides technical oversight and stewardship for peptide manufacturing processes. It leads resolution of technical issues, including those involving control strategy and manufacturing; supports process and product characterization and effective documentation; and ensures processes remain compliant, capable, in control, and validated or qualified. The role also supports validation-state assessment using data, contributes to the network technical agenda and continuous improvement, and helps maintain peptide processes in compliance with US and global regulations. The scientist is expected to build relationships with development and central technical organizations and coach and mentor peers and other scientists.

Some travel of less than 25% is required. Some off-shift work, including nights or weekends, may be required to support 24/7 operations. Candidates must be legally authorized to work in the United States; Lilly does not anticipate providing employment visa sponsorship.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmacy, Engineering, or another scientific discipline; Chemistry or Biochemistry is strongly preferred.
• At least 3 years of demonstrated experience and proficiency in pharmaceutical manufacturing.
• Working knowledge of regulatory expectations.

Nice To Haves

• 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 with diverse groups on business or technical issues within the site and function.
• Proficiency in delivering complex tasks and/or cross-functional tasks.
• Demonstrated project management skills and ability to coordinate complex projects.

Responsibilities

• Provide technical oversight and stewardship for peptide manufacturing processes.
• Lead resolution of technical issues, including issues related to control strategy and manufacturing.
• Manage internal and external relationships through effective communication.
• Build and maintain relationships with development and central technical organizations.
• Ensure processes and products are properly characterized and that process descriptions, measures, acceptable ranges, specifications, and their justifications are effectively documented.
• Ensure processes are compliant, capable, in control, and maintained in a validated or qualified state.
• Understand, justify, and document validation status using data that evaluate the manufacturing process’s capability to meet its stated purpose.
• Influence and implement the network technical agenda and drive continuous improvement.
• Maintain peptide processes in compliance with US and global regulations.
• Apply scientific principles to manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
• Coach and mentor peers and other scientists while operating with a Team Lilly mindset.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior