Sr. Scientist Technical Services/Manufacturing Science API-EM

Role Summary

Sr. Scientist Technical Services/Manufacturing Science API-EM at Lilly. Provides technical and scientific expertise within a dynamic external manufacturing environment to ensure reliable and compliant manufacture of API drug substance at external contract manufacturing groups to global quality standards. Works cross-functionally with internal and external partners to support ongoing manufacturing, process monitoring, issue response, and continuous improvement. This is a Large Molecule (mAb) position requiring knowledge of cGMPs and regulatory guidance, located onsite in Indianapolis, IN.

Responsibilities

• 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 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 mAb 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 ‚ÄòTeam Lilly‚Äô in mind

Qualifications

• Required: Bachelor‚Äôs in Biotech, Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Biotech/Biochemistry strongly preferred).
• Required: 3+ years of hands-on experience with pharmaceutical manufacturing and working knowledge of regulatory expectations.

Additional Requirements

• 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

Location

Onsite in Indianapolis, IN. Relocation provided. Some travel and potential off-shift work (night/weekend) may be required to support 24/7 operations.