Principal Scientist Deviation Management Lilly Medicine Foundry

Lilly • Indianapolis, IN

7d • $65,250 - $169,400 • Onsite

About The Position

Lilly is investing $4.5 billion to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. This facility will combine research and manufacturing to optimize processes, increase capacity for clinical trial medicines, reduce costs, and minimize environmental impact. The Analytical GMP Laboratories (AGL) within the Lilly Medicine Foundry (LMF) supports GMP testing across the facility and the broader Product Research & Development (PRD) network. This role offers the opportunity to shape the analytical compliance program from the ground up and foster a quality culture at a cutting-edge facility. The Principal Scientist – Deviation Management will lead deviation and out-of-specification (OOS) investigations, root cause analysis, CAPA development, and change control for AGL at the Lilly Medicine Foundry. This role involves authoring clear, defensible investigation reports and CAPA plans, performing hands-on troubleshooting, serving as a quality champion, and mentoring junior investigators.

Requirements

• BS in Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, Biology, or a related scientific/technical discipline.
• BS with 6+ years or MS with 3+ years of progressive GMP manufacturing, quality, or laboratory experience, including direct experience with deviation and OOS investigations, root cause analysis, and CAPA.
• Demonstrated experience authoring investigation protocols, technical reports, and CAPA plans in a regulated environment.
• 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.

Nice To Haves

• Working knowledge of ICH guidelines, FDA regulations (21 CFR Parts 210/211), and cGMP/data integrity (ALCOA+) principles as applied to investigations, CAPA, and change control in a phase-appropriate clinical development environment.
• Experience with electronic quality management systems (e.g., TrackWise, Veeva QMS) and lab informatics/GMP documentation platforms for deviation, CAPA, and change control records.
• Strong root cause analysis skills using structured methodologies (5-Why, fishbone/Ishikawa, fault tree, Is/Is-Not), with the ability to select the right tool for the complexity of the deviation.
• Demonstrated technical writing skills for protocols, investigation reports, and CAPA plans that hold up to regulatory review, paired with hands-on troubleshooting experience on GMP manufacturing equipment or analytical instrumentation.
• Experience drafting and assessing change controls and risk/impact assessments for validated systems, familiarity with Quality Risk Management (QRM) tools (e.g., FMEA), and understanding of lot association within deviations.
• Strong critical thinking and leadership skills — comfortable driving decisions independently, communicating with accountability and intellectual humility, and presenting findings to cross-functional teams and leadership.
• Experience mentoring junior investigators and supporting regulatory inspections (FDA, EMA, or equivalent) or audits related to deviations, CAPA, and change control.

Responsibilities

• Lead deviation and out-of-specification (OOS) investigations (Minor, Major, Critical), applying structured root cause analysis methods to determine true root cause.
• Author and review deviation reports, investigation protocols, and CAPA plans with clear, defensible rationale that meets data integrity (ALCOA+) standards and holds up to regulatory scrutiny.
• Draft CAPA plans that are risk-appropriate, measurable, and linked to verified root causes, and author change control records assessing impact to validated processes, equipment, and systems.
• Perform hands-on troubleshooting and confirmatory testing to distinguish true deviations from analytical or process anomalies.
• Partner with QA, SMEs, and stakeholders to keep the deviation portfolio on track for right-first-time, on-time completion.
• May lead Deviation Review Board meetings.
• Serve as a thought leader on the Analytical Compliance Excellence (ACE) team, championing quality priorities across AGL and supporting audit and inspection readiness.
• Drive process improvement based on deviation metric analysis, contributing to AGL's continuous improvement roadmap.
• Support data integrity and training initiatives.
• Lead cross-functional analysis of investigation trends and deviation metrics, translating data into actionable insights.
• Track deviation, OOS, CAPA, and change control records to closure, escalating at-risk items to leadership.
• Mentor junior investigators and analytical staff on root cause analysis, technical writing, and quality impact evaluation.
• Serve as a go-to resource for GMP compliance and investigation strategy across AGL.
• Partner with Manufacturing, Quality Assurance, Analytical/QC, Engineering, and AGL branch leads to scope investigations, verify corrective actions, and confirm CAPA effectiveness.
• Engage the broader PRD network and external labs for cross-site work as needed.
• Collaborate closely with the Senior Advisor on investigation strategy, CAPA prioritization, and change control decisions requiring elevated judgment.
• May participate in deviation governance teams and other quality initiatives.

Benefits

• company bonus (depending, in part, on company and individual performance)
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

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