Advisor, Manufacturing Quality Assurance - Lilly Medicine Foundry

Overview

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world. Lilly is a global healthcare leader headquartered in Indianapolis, Indiana with employees worldwide who work to develop and deliver medicines, improve disease understanding and management, and contribute to communities through philanthropy and volunteerism.

We are seeking individuals determined to make life better for people around the world.

Lilly announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The Foundry will combine research and manufacturing to optimize processes, increase capacity for clinical trial medicines, reduce costs, and lower environmental impact. The startup phase is expected to complete in 2027; initial roles will be fluid to support startup activities, establish systems and processes for GMP operations, and build site culture.

Once startup activities are completed, the Foundry, Manufacturing Quality Assurance, will mentor QA and cross-functional teams and provide on-site quality oversight of GMP operations.

• Participate in creating and maintaining a safe work environment, including leading and enabling safety efforts for the Quality team.
• Support cross-functional teams, facilitate decision making, and drive progress.
• Support the execution of the site operational readiness plan, including development of early phase quality processes, procedures, and controls.
• Foster a collaborative quality culture with open communications and strong teamwork across work groups and cross-functional teams.
• Ensure compliance with applicable laws, regulations, and guidelines to support early phase GMP activities.
• Review and approve GMP documentation (procedures, deviations, technical reports, change controls, etc.).
• Work cross-functionally with plant teams to develop processes, provide operational support, and manage issues.
• Assist with inspection readiness activities.
• Facilitate decision making within the team under tight deadlines.
• Communicate effectively with internal and external stakeholders.
• Participate in global communities of practice and committees to benchmark and share learning.
• Lead process improvement projects impacting multiple business areas.

• BA/BS degree in Engineering, Science, or related field with a minimum of 6 years of technical and/or quality experience in Biotech or Pharmaceutical FDA-regulated industry.
• Strong understanding of GMP requirements for early phase API development and manufacturing and application of quality management systems.
• 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.

• Experience in API manufacturing of small and/or large molecules and/or high potency antibody drug conjugates (ADC).
• Experience with applicable equipment cleaning requirements.
• Relevant industry experience in a high-paced working environment.
• Proven experience identifying innovative processes and implementing them with a focus on quality and acceleration.
• Strong oral and written communication skills.
• Critical thinking and technical problem-solving skills, including root cause analysis and troubleshooting.
• Flexibility to adapt quickly to frequent changes and shifting priorities.
• Ability to influence decision making on complex technical issues and establish key relationships with peers and business partners.
• Ability to identify, prioritize, and implement solutions effectively.
• High learning agility and comfort with ambiguity and uncertainty.
• Attention to detail and, for internal Lilly employees, LRL/Product Research Development experience preferred.

• Initial location at Parkwood West, Indianapolis, Indiana; permanent location at the Lilly Medicines Foundry in Lebanon, Indiana.
• Travel: 5% to 15%.
• On-call support may be required outside normal 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 or expression, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer support networks and are open to all employees.

Actual compensation will depend on education, experience, skills, and location. The anticipated wage for this position is $126,000 - $204,600. Full-time employees may be eligible for a company bonus and a comprehensive benefits program, including a 401(k) plan, medical/dental/vision coverage, flexible spending accounts, life insurance, paid time off, and well-being benefits. Lilly reserves the right to amend compensation and benefits as needed.