Freelance Clinical Study Startup Jobs in Indiana

Organization Overview

Lilly recently announced a$4.5 billioninvestment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development in Lebanon, Indiana. The first-ever facility of its kind combining research and manufacturing ina single location, the Medicine Foundry will allow Lilly to further develop innovative solutions tooptimizemanufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

In the Foundry Construction and Project Delivery/Startup Phase (2025 to 2028), roles will be fluid and dynamic as we build a new organization, design and implement the necessary systems and business processes required to enable operational readiness, support project delivery, and build the site culture. Success will require significant collaboration, creativity, and resilience as the Lilly Medicine Foundry transitions from design to startup andultimately tosteady-state operations and continuous improvement. This period presents a unique opportunity for learning, growth, and making a lasting impact.

Position Purpose

The Principal/Senior Principal Scientist, Sample Management provides operational leadership and subject matterexpertisefor sample management within the Analytical Laboratories at the Lilly Medicine Foundry. This roleis responsible forensuring 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 MedicineFoundrymovesthrough its startup and commissioning phase toward lab operationalization and steady-state operations beyond, this role plays a key part inestablishingthe 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 tomaintaininspection-readiness and support testing timelines.

Key Responsibilities

Sample Management Operations

• 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 andmaintainchain-of-custody documentation and sample integrity controls across laboratory spaces.

• Manage sample storage environments including ambient, refrigerated, freezer, and controlled-humidity conditions, ensuring storage unitsremainwithin qualified temperature/humidity ranges to preserve sample integrity.

• Implement workflows for sample lifecycle management within LIMS/ELN, ensuringaccuratestatus tracking from receipt through disposition.

• Coordinate shipmentlogisticsfor 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,maintainingchain-of-custody documentation and sample integrity throughout the transfer.

Compliance, Documentation & Systems

• Author, review, andmaintainSOPs, work instructions, and forms related to sample management operations, partnering with Quality Assurance to ensure all documentation meets GMP and regulatory compliance requirements.

• Ensure activitiescomply withFDA 21 CFR Part 211, ICH guidelines, and applicable Lilly quality standards.

• Support audit andinspectionreadiness and serve as a subject matter expert during regulatory and internal audits.

• Manage GMP documentation within electronic quality and laboratory systems including LIMS (LabVantageor equivalent), ELN, and document control platforms.

• Drive continuous improvement initiatives for sample management workflows and documentation efficiency.

Cross-Functional Collaboration & Stakeholder Engagement

• 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 tomaintainup-to-date sample managementSOPsare current and ensuretimelycompletion of team training requirements.

• Communicate effectively across functional boundaries, escalating issuesappropriatelyandmaintaininga customer-focused approach to service delivery.

Basic Qualifications

• Bachelor's orMaster's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline

• BS with5+ years, MS with2+ yearsof experiencesupportingsample management or related laboratory operationsin a regulated environment (GxP, GLP, GMP).

• Qualified applicants mustbe authorized towork 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 Additional 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 withdemonstratedability 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

• Proficiencyin 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 berequiredfor this role.