Sr. Scientist Technical Services/Manufacturing Science API-EM
Indianapolis, Marion County, Indiana, 46262, USA
Listed on 2025-11-22
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IT/Tech
Data Scientist, Data Analyst
Sr. Scientist Technical Services/Manufacturing Science API-EM
Join to apply for the Sr. Scientist Technical Services/Manufacturing Science API-EM role at Eli Lilly and Company
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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana, and our employees work to discover and bring life‑changing medicines to those who need them. We improve the understanding and management of disease, give back to our communities through philanthropy and volunteerism, and put people first.
We’re looking for people who are determined to make life better for people worldwide.
Join the energetic and growing Active Pharmaceutical Ingredient – External Manufacturing Organization (API‑EM). 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.
You will interact daily with a wide variety of people, primarily external partners, team members, and site management. This is a Large Molecule (mAb) position requiring knowledge of cGMPs, global regulatory guidance, and corporate/industry standards. You will collaborate cross‑functionally to deliver on technical objectives.
- Provide technical oversight for monoclonal antibody manufacturing processes, leveraging a strong technical foundation and previous experience supporting these 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 the process description, measures, acceptable ranges, and specifications.
- 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 that evaluate the capability of the manufacturing process to meet its stated purpose.
- Influence and implement the network technical agenda and drive continuous improvement.
- Maintain mAb 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 the process and equipment.
- Operate with ‘Team Lilly’ in mind.
- Bachelor’s degree in a scientific discipline such as Biotechnology, Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Biotech/Biochemistry strongly preferred).
- 3+ years of hands‑on experience and proficiency with pharmaceutical manufacturing and a strong working knowledge of regulatory expectations.
- Strong understanding of regulatory requirements and their application in a manufacturing environment.
- Proficiency in data management practices across manufacturing operations.
- Demonstrated 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.
- Some travel may be 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.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form at
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