Associate, Quality Assurance, Manufacturing Operations, Lilly Medicine Foundry

Lilly • Indianapolis, IN

12d • $65,250 - $169,400

About The Position

Lilly is establishing the Lilly Medicine Foundry, a new advanced manufacturing and drug development center that will combine research and manufacturing at one site. During the Foundry’s design, construction, and startup phase, the role will help deliver the facility, build the organization, develop and implement systems and business processes for GMP operations, and establish the site culture. This work will require collaboration, creativity, and resilience as the site develops into a full-scale GMP manufacturing facility.

After startup activities are complete, the Associate, Quality Assurance, Manufacturing Operations will provide day-to-day Quality Assurance oversight of GMP manufacturing operations on the production floor. The role will review change management and investigations, support plant operations and issue management, and perform other assigned activities. The initial position is based in Indianapolis, Indiana, with a future location at Lilly Medicine Foundry Operations in Lebanon, Indiana. Travel is expected to be 5%–15%, and on-call support outside normal working hours, including nights, weekends, and holidays, may be required.

Requirements

• Bachelor of Arts or Bachelor of Science degree in Engineering, Science, or another related field.
• At least 2 years of technical and/or quality experience in a biotech or pharmaceutical FDA-regulated industry.
• Understanding of GMP requirements for early-phase development and manufacturing and of quality management systems.
• Must be authorized to work in the United States on a full-time basis; Lilly will not sponsor work authorization or visas for this role.

Nice To Haves

• Effective project and time-management skills.
• Ability to prioritize and manage multiple concurrent tasks.
• Problem-solving, verbal-reasoning, attention-to-detail, critical-thinking, and analytical abilities.
• Strong oral and written communication skills.
• Effective organization and self-management skills.
• Relevant experience in a cGMP facility.
• Relevant industry experience in a fast-paced working environment.
• Critical thinking and technical problem-solving skills, including root-cause analysis and troubleshooting.
• Flexibility to adapt quickly and effectively to frequent changes and shifting priorities.
• Ability to identify and prioritize issues and develop and implement solutions.
• High learning agility and ability to work with ambiguity and uncertainty.
• Demonstrated attention to detail.

Responsibilities

• Participate in creating and maintaining a safe work environment.
• Foster a collaborative quality culture by maintaining open communication and promoting teamwork and employee participation within the work group and across cross-functional teams.
• Ensure compliance with applicable laws, regulations, and guidelines supporting GMP activities.
• Review GMP documentation, including procedures, deviations, technical reports, and change controls.
• Work cross-functionally with plant teams to provide operational support and address issues.
• Assist with inspection-readiness activities.
• Communicate effectively with internal and external stakeholders.
• Following startup activities, provide day-to-day Quality oversight of GMP operations and review change management and investigations.

Benefits

• Company bonus, depending in part on company and individual performance.
• Company-sponsored 401(k) eligibility.
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefit eligibility.
• Flexible benefits, including healthcare and/or dependent day-care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level