Principal Scientist Sample Management Lilly Medicine Foundry

Position Purpose

The Principal/Senior Principal Scientist, Sample Management provides operational leadership and subject matter expertise for sample management within the Analytical Laboratories at the Lilly Medicine Foundry. This role is responsible for ensuring compliant receipt, storage, distribution, tracking, and disposition of both GMP and non-GMP samples across all modalities including small molecules, synthetic peptides, oligonucleotides, biologics, and bioconjugates. As the Lilly Medicine Foundry moves through its startup and commissioning phase toward lab operationalization and steady-state operations beyond, this role plays a key part in establishing the foundational workflows, systems, and documentation needed to support analytical operations at scale. The role requires close cross-functional partnership with Manufacturing, Quality Assurance, Supply Chain, Process Translation & Execution, and other site functions to maintain inspection-readiness and support testing timelines.

Key Responsibilities

• Lead day-to-day sample management operations including login, receipt, storage, tracking, distribution, and disposition of non-GMP and GMP samples in compliance with cGMP requirements and applicable SOPs.
• Establish and maintain chain-of-custody documentation and sample integrity controls across laboratory spaces.
• Manage sample storage environments including ambient, refrigerated, freezer, and controlled-humidity conditions, ensuring storage units remain within qualified temperature/humidity ranges to preserve sample integrity.
• Implement workflows for sample lifecycle management within LIMS/ELN, ensuring accurate status tracking from receipt through disposition.
• Coordinate shipment logistics for samples sent to external laboratory partners, including shipment setup and review of temperature-monitoring results to confirm samples remained within acceptable conditions during transit.
• Coordinate outbound shipment of stability samples to the designated offsite stability facility on a study-driven schedule, maintaining chain-of-custody documentation and sample integrity throughout the transfer.
• Author, review, and maintain SOPs, work instructions, and forms related to sample management operations, partnering with Quality Assurance to ensure all documentation meets GMP and regulatory compliance requirements.
• Ensure activities comply with FDA 21 CFR Part 211, ICH guidelines, and applicable Lilly quality standards.
• Support audit and inspection readiness and serve as a subject matter expert during regulatory and internal audits.
• Manage GMP documentation within electronic quality and laboratory systems including LIMS (LabVantage or equivalent), ELN, and document control platforms.
• Drive continuous improvement initiatives for sample management workflows and documentation efficiency.
• Partner with Manufacturing, Quality Assurance, Supply Chain, and Process Translation & Execution to ensure integrated sample flow and testing turnaround targets are met.
• Partner with reference standard functions on sample management touchpoints including storage coordination, inventory alignment, and chain-of-custody handoffs as applicable.
• Partner with Documentation & Method Readiness and Learning & Development functions to maintain up-to-date sample management SOPs are current and ensure timely completion of team training requirements.
• Communicate effectively across functional boundaries, escalating issues appropriately and maintaining a customer-focused approach to service delivery.

Basic Qualifications

• Bachelor's or Master's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline.
• BS with 5+ years, MS with 2+ years of experience supporting sample management or related laboratory operations in a regulated environment (GxP, GLP, GMP).
• 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.

Preferred Qualifications

• Experience in a GMP pharmaceutical or biopharmaceutical laboratory environment or Quality Control or analytical laboratory in a lead, senior, or team coordinator capacity.
• Proficiency with computer systems including Microsoft Office products, LIMS, Laboratory Execution Systems, chromatography systems, electronic laboratory notebook systems.
• Strong organizational skills with demonstrated ability to manage competing priorities.
• Strong written and verbal communication skills with comfort engaging cross-functionally.
• Working knowledge of ICH guidelines and FDA 21 CFR Parts 211/212.
• Familiarity with temperature-controlled storage management and environmental monitoring systems.
• Experience supporting regulatory inspections (FDA, EMA) or internal quality audits.
• Experience working in a startup or newly established laboratory environment.
• Proficiency in electronic quality and laboratory systems such as MODA, Empower, or ELN platforms.

Additional Information

• 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.
• The role may require occasional weekend or off-hours support for sample receipt or inspection activities.
• Limited domestic and international travel (< 10%) may be required for this role.