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, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry — the first-ever facility to combine research and manufacturing in a single location, expanding capacity for clinical trial medicines while reducing costs and environmental impact. Analytical GMP Laboratories (AGL) supports GMP testing across the Lilly Medicine Foundry (LMF) and the broader Product Research & Development (PRD) network, spanning environmental monitoring, microbiology, GMP testing, raw materials, and cleaning/investigations. AGL sits at the intersection of science and quality — this role offers the opportunity to shape the analytical compliance program from the ground up and help drive quality culture at a cutting-edge facility. The Principal Scientist, GMP QC Microbiology is 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. The role executes and oversees compendial and non-compendial microbiological testing including sterility, bioburden, endotoxin (Bacterial Endotoxin Test), microbial limits, and water testing; leads laboratory investigations; authors change controls and SOPs; and trains and mentors junior analysts. Partnering with the Sr. Advisor, Quality Assurance, Manufacturing, and Regulatory Affairs, the role contributes to method validation and inspection readiness in compliance with cGMP, data integrity (ALCOA+), EU GMP Annex 1, and applicable global regulatory requirements.

• What You'll Do
• Testing & batch disposition
• + Perform and oversee sterility, bioburden, microbial limits, and water system testing; serve as primary data reviewer foraccurateandtimelybatch disposition. + Perform microbial identificationtesting andmaintainthe site isolate library; supportEM activities as back-up coverage.
• Method validation & change control
• + Lead method validations, transfers, and verifications; prepare protocols and summary reports and authorchange controls for test methods, specifications, and SOPs. + Support qualification of laboratory equipment andevaluate newrapid microbiological methods (RMM).
• Investigations, OOS & CAPA
• + Lead OOS/OOT andother laboratoryinvestigations; author deviation reports and drive CAPA to closure with QA.
• Regulatory compliance & audit readiness
• + Maintain documentation in a state of inspection readiness, serve as SME during inspections and audits, andsupport remediation of audit observations to closure. + Stay current onapplicable compendial standardsandregulatory requirements; update SOPs to reflect evolving requirements.
• Training, mentorship & continuous improvement
• + Develop and deliver training for junior analysts on test methods, aseptictechnique, andcGMP; serve asaqualifiedtrainer;andmaintaintraining records and competency matrices. + Partner with the Advisor on lab workflow andcontinuous improvementinitiatives. Handle biohazardous and hazardous materials per EHS requirements.
• Safety and GMP execution
• + Ensure laboratory, cleanroom, and manufacturing support activities are performed safely andin accordance withapproved procedures, cleanroom behaviors, and GMP expectations.
• Minimum Qualifications
• + BS or MS in 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.

+ 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, including but not limited to

F-1 CPT, F-1 OPT, F-1 STEM

OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

• Additional Skills and Preferences
• + Experience with aseptic manufacturing or sterile drug product operations (fill-finish, lyophilization).

+ Proficiencywith 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). Priorworkwith 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, equipmentselectionand qualification, andestablishinga quality culture from the ground up.

• Additional Information
• +

Location:

Initial location at Parkwood West, Carmel, IN, with occasional work at Lilly Technology Center, Indianapolis. Permanent location at the Lilly Medicine Foundry in Lebanon, IN. +

Travel:

Less than 5% domestic + Regular work in controlled cleanroom environments (ISO 5-8 / Grade A-D) requiring gowning per applicable SOP requirements. + May require occasional off-hours,weekend, or on-call availability to support critical manufacturing campaigns or investigationresponse. + Physical requirements include standing for extended periods, walking throughout the facility, and performing gowning activities. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees.

Our current groups include:

Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL). Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly