Principal Scientist GMP Microbiology Lilly Medicine Foundry

Lilly • Indianapolis, IN

3d • $65,250 - $169,400 • Hybrid

About The Position

Lilly is investing $4.5 billion to create the Lilly Medicine Foundry, a first-of-its-kind facility combining research and manufacturing to expand capacity for clinical trial medicines while reducing costs and environmental impact. The Analytical GMP Laboratories (AGL) supports GMP testing across the Lilly Medicine Foundry (LMF) and the broader Product Research & Development (PRD) network. This role offers the opportunity to shape the analytical compliance program from the ground up and drive quality culture at a cutting-edge facility. The Principal Scientist, GMP QC Microbiology will serve as the subject matter expert supporting the Sr. Advisor of Env. Monitoring & Microbiology in day-to-day microbiological testing and batch disposition for clinical GMP manufacturing at the Medicine Foundry Analytical GMP Laboratory. This role will execute and oversee compendial and non-compendial microbiological testing, lead laboratory investigations, author change controls and SOPs, and train and mentor junior analysts. Partnering with key stakeholders, the role will contribute to method validation and inspection readiness in compliance with cGMP, data integrity (ALCOA+), EU GMP Annex 1, and applicable global regulatory requirements.

Requirements

• BS or MS in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or related technical discipline
• BS with 5+ years or MS with 3+ years of experience in cGMP pharmaceutical microbiology experience, including compendial method execution, investigation authoring, and analyst mentoring.
• Equivalent combinations of education and cGMP microbiology experience will be considered.

Nice To Haves

• Experience with aseptic manufacturing or sterile drug product operations (fill–finish, lyophilization).
• Proficiency with EM data systems including MODA, LabVantage, Metasys, and quality management systems (TrackWise, Veeva Vault).
• Experience with RMM platforms (BacT/ALERT, Bactec, Milliflex, NAT/PCR sterility).
• Prior work with LIMS, ELN, LabVantage, TrackWise, or Veeva Vault.
• Working knowledge of microbial identification techniques (MALDI-TOF, Vitek, Gram stain).
• Experience working in a greenfield or start-up laboratory environment, including contributing to lab build-out, SOP authoring from scratch, equipment selection and qualification, and establishing a quality culture from the ground up.

Responsibilities

• Perform and oversee sterility, bioburden, microbial limits, and water system testing; serve as primary data reviewer for accurate and timely batch disposition.
• Perform microbial identification testing and maintain the site isolate library; support EM activities as back-up coverage.
• Lead method validations, transfers, and verifications; prepare protocols and summary reports and author change controls for test methods, specifications, and SOPs.
• Support qualification of laboratory equipment and evaluate new rapid microbiological methods (RMM).
• Lead OOS/OOT and other laboratory investigations; author deviation reports and drive CAPA to closure with QA.
• Maintain documentation in a state of inspection readiness, serve as SME during inspections and audits, and support remediation of audit observations to closure.
• Stay current on applicable compendial standards and regulatory requirements; update SOPs to reflect evolving requirements.
• Develop and deliver training for junior analysts on test methods, aseptic technique, and cGMP; serve as a qualified trainer; and maintain training records and competency matrices.
• Partner with the Advisor on lab workflow and continuous improvement initiatives.
• Handle biohazardous and hazardous materials per EHS requirements.
• Ensure laboratory, cleanroom, and manufacturing support activities are performed safely and in accordance with approved procedures, cleanroom behaviors, and GMP expectations.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• Education Level: Associate degree