Sr. Scientist Technical Services/Manufacturing Science API-EM
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-07-01
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Pharmaceutical
Regulatory Compliance Specialist, Pharmaceutical Manufacturing, Pharmaceutical Science/ Research, Validation Engineer
Organization Overview
Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API‑EM) that delivers a diverse portfolio of medicines essential to patients worldwide. The API‑EM TS/MS (Technical Services / Manufacturing Science) 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 in accordance with global quality standards.
The role interacts daily with external partners, internal team members, and site management.
- Provide technical oversight for biologics 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 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 biologic processes in compliance with US and global regulations.
- Understand the scientific principles required for manufacturing intermediates and drug substances, including the interaction of process and equipment.
- Operate with a “Team Lilly” mindset.
- Bachelor’s degree in a scientific discipline such as Biotech, Chemistry, Biochemistry, Biology, Pharmacy, or Engineering;
Biotech/Biochemistry strongly preferred. - Three or more years of hands‑on experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.
- Authorized to work in the United States on a full‑time basis; role does not provide visa sponsorship.
- Strong understanding of regulatory requirements and their application in a manufacturing environment.
- Proficiency 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.
- 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 assistance will be provided.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage range for this position is $66,000 – $171,600. Full‑time employees will also be eligible for a company bonus in addition to a comprehensive benefit program, including a 401(k) with company match, pension, vacation, medical, dental, vision, prescription drug, flexible spending accounts, life insurance, disability benefits, time‑off and leave options, and well‑being initiatives such as an employee assistance program and fitness benefits.
Lilly is proud to be an EEO Employer and does not discriminate based on age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
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