Sr. Scientist Technical Services/Manufacturing Science API-EM Full-time

Active Pharmaceutical Ingredient – External Manufacturing Scientist

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Join the energetic and growing Active Pharmaceutical Ingredient – External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API-EM TS/MS (Technical Services / Manufacturing Science) Scientist will provide technical and scientific expertise within a dynamic external manufacturing environment. The Scientist is responsible for providing technical support to achieve the reliable and compliant manufacture of API drug substance at external contract manufacturing groups to predetermined global quality standards. This person interacts daily with a wide variety of people, primarily external partners team members and site management.

The candidate will be responsible for supporting ongoing manufacturing at our External Partners through tasks such as process monitoring, response to issues, and improvements where necessary. A strong understanding of manufacturing principles and Lilly systems is required to ensure those same standards are applied to the external contract manufacturers.

This is a Biologics (Mabs, Recombinant Enzymes, ADC) position. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. The position requires working cross-functionally within the site and other functions to deliver on technical objectives.

Responsibilities:

• Provide technical oversight for biologics manufacturing processes, leveraging a strong technical foundation and previous experience supporting these processes.
• Leads 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 ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications).
• Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.
• Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
• Influence and implement the network technical agenda and drive continuous improvement.
• Maintaining biologic processes in a state of compliance with US and global regulations.
• Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of the process and equipment.
• Operate with 'Team Lilly' in mind.

Basic Requirements:

• Bachelors in scientific disciplines of Biotech, Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Biotech/Biochemistry strongly preferred)
• 3+ years of demonstrated hands on working experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences:

• Strong understanding of regulatory requirements and their application in a manufacturing environment
• Proficient in data management practices across manufacturing operations
• Demonstrates adaptability, a collaborative mindset, and a positive attitude toward change
• Proven ability to effectively communicate and influence across diverse technical and business teams
• Skilled in managing and delivering complex, cross-functional initiatives
• Demonstrated project management expertise with a track record of coordinating and executing multifaceted projects

Additional Information:

• Some travel (<25%) is required
• Some off-shift work (night/weekend) may be required to support 24/7 operations.

This position is located onsite in Indianapolis, IN and is not approved for remote work. Relocation will be provided.