Principal Scientist GMP Microbiology Lilly Medicine Foundry

About the role

The Principal Scientist, GMP QC Microbiology supports 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 involves executing and overseeing compendial and non-compendial microbiological testing, leading method validations, investigations, OOS/OOT and other laboratory investigations, and staying current on regulatory requirements.

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.

Requirements

• BS or MS in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or related technical discipline
• 5+ years of experience in cGMP pharmaceutical microbiology experience, including compendial method execution, investigation authoring, and analyst mentoring

Qualifications

• 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)
• 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

Skills

• Experience with aseptic manufacturing or sterile drug product operations (fill–finish, lyophilization)
• Experience with LIMS, ELN, LabVantage, TrackWise, or Veeva Vault

Benefits

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).

Pay

The anticipated wage for this position is $65,250 - $169,400

Schedule

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 investigation response.

Physical requirements

• Standing for extended periods
• Walking throughout the facility
• Performing gowning activities