Sr. Scientist Technical Services/Manufacturing Science API-EM

About the role

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.

Responsibilities

• Provide technical oversight for biologics manufacturing processes, leveraging a strong technical foundation and previous experience supporting these processes.
• Lead the 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).
• Achieve compliance, capability, and control of processes and ensure they are maintained in a validated or qualified state.
• Influence and implement the network technical agenda and drive continuous improvement.
• Maintain biologic processes in a state of compliance with US and global regulations.
• Understand, justify, and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
• Operate with 'Team Lilly' in mind.

Requirements

• Bachelor's degree 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.
• Working knowledge of regulatory expectations.

Qualifications

• 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.

Skills

• Strong understanding of manufacturing principles and Lilly systems.
• Knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards.

Benefits

Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Pay

The anticipated wage for this position is $66,000 - $171,600.

Schedule

This position is located onsite in Indianapolis, IN and is not approved for remote work. Some travel and off-shift work (night/weekend) may be required to support 24/7 operations.