Associate, Quality Assurance, Process Manufacturing-Lilly Medicine Foundry

Organization and Position Overview

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

• Participate in creating and maintaining a safe work environment including leading/enabling safety efforts for the Quality team.
• Support cross-functional teams, facilitate decision making and drive progress.
• Foster a strong collaborative quality culture including maintaining open communications and promoting teamwork and employee participation in the work group and with cross-functional teams.
• Ensure compliance with applicable laws, regulations, and guidelines to support early phase GMP activities.
• Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.
• Influence and oversee Facility, Utility, Maintenance and Equipment (FUME) Qualification/Maintenance/Calibration programs.
• Facilitate decision making within the team under tight deadlines.
• Effectively communicate with internal and external stakeholders.

• BA/BS degree in Engineering, Science, or related field with a minimum of 3 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry.
• Understand GMP requirements for early phase development and manufacturing and application of quality management systems.
• Prior experience in equipment/utilities qualification, calibration and maintenance.
• 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.

• Demonstrated relevant experience in a cGMP facility.
• Relevant industry experience in high paced working environment.
• Demonstrated strong oral and written communication skills.
• Critical thinking and technical problem-solving skills, including root cause analysis/troubleshooting skills.
• Flexibility to adjust quickly and effectively to frequent changes and altered priorities.
• Ability to establish key relationships and influence peers and business partners.
• Ability to identify and prioritize issues and develop & implement solutions.
• High learning agility and ability to deal with ambiguity, uncertainty.
• Demonstrated attention to detail.

• Initial location at Parkwood West, Indianapolis, Indiana.
• Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.
• Travel Percentage: 5% - 15%
• May be required to provide on‑call support outside of normal working hours including nights, weekends, and holidays.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of 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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400.

Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, 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). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.