Sr. Principal Scientist - QA

Lilly • Indianapolis, IN

11d • $66,000 - $171,600 • Onsite

About The Position

The Sr. Principal Scientist - QA assures and verifies that Quality Assurance responsibilities and expectations support radioligand drug product manufacturing. The role provides Quality oversight during aseptic drug product manufacturing and performs final quality disposition of drug products at Lilly’s Indianapolis Radioligand Therapies (IRLT) production site.

The position supports safe operations and provides hands-on QA coverage across manufacturing and Quality Control activities, including real-time batch record review, media fills, quality escalations, batch disposition, floor support, and inspection readiness. It also reviews manufacturing-supporting documentation, contributes to site operational readiness, and drives improvements to operational performance and disposition processes through data analysis and cross-functional collaboration.

The role provides technical expertise, training, mentoring, and coaching to QA, operations, and support personnel. Work includes entering manufacturing and controlled areas where radioactive materials may be present; appropriate PPE, special training, and exposure monitoring are required.

Requirements

• Bachelor’s degree in science, engineering, computer, pharmaceutical-related field of study, or a related technical degree.
• At least 5 years of experience in QA/QC roles in the pharmaceutical industry.
• Authorization to work in the United States on a full-time basis; the employer will not sponsor work authorization or visas for this role.

Nice To Haves

• Ability to work independently and bring cross-functional team members and management together as needed to manage potential failure modes, correct errors, and remain organized and productive in a fast-paced team environment.
• Strong knowledge of Quality Management Systems and applicable regulatory requirements.
• Previous regulatory inspection readiness and inspection execution experience.
• Previous experience with Manufacturing Execution Systems and electronic batch release.
• Excellent interpersonal, written, and oral communication skills.
• Previous experience working with radioligands.

Responsibilities

• Support a safe work environment, including safety efforts for the QA Operations team.
• Provide Quality support to IRLT, including real-time review of batch records on the floor, media-fill coverage, and first-line support for quality escalations affecting manufacturing processes or Quality Control operations.
• Verify that documented in-process checks and required records—including deviations, changes, and batch documentation—are complete and demonstrate requirements have been met before batch release.
• Disposition drug product batches and drug substance intermediates.
• Maintain a regular presence in operational areas as part of QA floor support, helping ensure GMP compliance and inspection readiness, and record observations according to local and global procedures.
• Plan and schedule task qualification and requalification activities.
• Train floor QA and batch QA personnel as a subject-matter expert and qualified trainer; oversee post-training execution and provide feedback to sustain compliance and develop the QA Operations organization.
• Provide technical and Quality review of manufacturing-supporting documentation, including deviations, changes, procedures, protocols, training documents, and analytical method validations, as applicable.
• Support development of the site operational readiness plan, including quality processes and approval of operational procedures.
• Use data analysis to drive operational excellence in floor operations and disposition processes, reduce variability, and improve performance cycle times to align with supply delivery targets.
• Work cross-functionally with area process teams on metrics reviews, operational support, and issue and deviation management.
• Assess and triage deviations in collaboration with the site process team.
• Lead, mentor, and coach operations and support personnel as a Quality subject-matter expert during manufacturing and QC troubleshooting.

Benefits

• Company bonus eligibility, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• 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: Principal