Sr. Scientist Technical Services/Manufacturing Science API-EM

Lilly • Indianapolis, IN

2d • $67,500 - $173,800 • Onsite

About The Position

The API-EM Technical Services/Manufacturing Science Scientist provides technical and scientific expertise to support reliable, compliant manufacture of biologic active pharmaceutical ingredients at external contract manufacturing organizations. The role supports ongoing manufacturing through process monitoring, issue response, and improvement, applying Lilly systems and standards alongside applicable global quality and regulatory requirements. The position focuses on biologics, including monoclonal antibodies, recombinant enzymes, and antibody-drug conjugates, and works cross-functionally with internal teams and external partners, including site management.

The Scientist provides technical oversight of manufacturing processes, leads resolution of technical and control-strategy issues, and ensures processes and products are properly characterized and documented. The role helps ensure manufacturing processes remain compliant, capable, in control, and in a validated or qualified state, using data to justify validation status and the ability of processes to meet their intended purpose. The position also supports the network technical agenda and continuous improvement.

This is an onsite position in Indianapolis, Indiana, and is not approved for remote work. Some travel of less than 25% and some off-shift work, including nights or weekends, may be required to support 24/7 operations. Relocation assistance will be provided.

Requirements

• Bachelor's degree in a scientific discipline such as biotechnology, chemistry, biochemistry, biology, pharmacy, or engineering; biotechnology or biochemistry is strongly preferred.
• At least 3 years of demonstrated hands-on working experience and proficiency in pharmaceutical manufacturing.
• Working knowledge of regulatory expectations.
• Must be authorized to work in the United States on a full-time basis; Lilly will not sponsor work authorization or visas for this role.

Nice To Haves

• Strong understanding of regulatory requirements and their application in a manufacturing environment.
• Proficiency in data management practices across manufacturing operations.
• Adaptability, a collaborative mindset, and a positive attitude toward change.
• Ability to communicate effectively and influence diverse technical and business teams.
• Skill in managing and delivering complex, cross-functional initiatives.
• Project management expertise and a track record of coordinating and executing multifaceted projects.

Responsibilities

• Provide technical oversight for biologics manufacturing processes, applying a strong technical foundation and relevant experience.
• 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 ability to meet its stated purpose.
• Influence and implement the network technical agenda and drive continuous improvement.
• Maintain biologic processes in compliance with U.S. and global regulations.
• Apply scientific principles for manufacturing intermediates and drug substances, including understanding interactions between processes and equipment.
• Operate with a “Team Lilly” mindset.

Benefits

• Relocation assistance.
• Company bonus eligibility, 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: Mid Level