Principal Scientist – CRO Lab Qualification & Onboarding, Bioanalytical Outsourcing

Eli Lilly and Company

. Lead qualification and onboarding of new CRO partners for ADME and bioanalytical assays .

Posted 9/30/2026full-timeIndianapolis • Massachusetts • United StatesLead💰 $69,000 - $195,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in bioanalytical method development, validation, and sample analysis within regulated environments, while effectively mentoring scientists and managing cross-functional collaborations. Proficient in establishing CRO qualification standards and fostering strategic relationships with internal and external stakeholders.

Highest-signal resume keywords

Bioanalytical Method DevelopmentCRO Qualification and OnboardingICH M10 BMV GuidanceLC-MS Bioanalytical MethodsProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Bioanalytical Method ValidationSample AnalysisRegulated Laboratory ExperienceTroubleshootingCritical Reagent ManagementSmall Molecule LC-MSLarge Molecule LC-MSScientific OversightData Delivery TimelinesMentoring Scientists

Soft Skills

Problem-SolvingTime ManagementOrganizationInfluencing Without AuthorityRelationship Building

Tools & Technologies

LIMSELNsInstrument Software

Industry Keywords

GLPGCPCROBioanalytical AssaysScientific Point of Contact

About the role

Key responsibilities & impact

Lead qualification and onboarding of new CRO partners for ADME and bioanalytical assays
Serve as primary scientific point of contact from technical assessment through integration
Provide scientific oversight and strategic guidance for regulated and non-regulated bioanalytical method development, validation, and sample analysis
Collaborate with Discovery, Non-Clinical, and Clinical teams to align CRO capabilities with program needs
Partner with Procurement, Quality, and Operations to establish and improve CRO qualification standards and processes
Build strategic relationships with internal customers and external vendors
Provide bioanalytical method support, troubleshooting, and critical reagent management
Mentor scientists and share technical expertise across the bioanalytical outsourcing network
Travel approximately 25%

Requirements

What you’ll need

Bachelor's degree in a scientific field with a minimum of 7 years of relevant bioanalytical laboratory experience, OR a Master's degree with a minimum of 5 years, OR a Ph.D. with a minimum of 2 years of relevant experience
Hands-on experience in a regulated bioanalytical laboratory setting, including method development, validation, and/or sample analysis
Understanding of current ICH M10 BMV guidance requirements and GLP/GCP regulations
Prior experience qualifying, onboarding, or providing scientific oversight to CRO or outsourced laboratory partners
Experience with sponsor-vendor interactions and relationship building
Ability to mentor scientists and influence cross-functional teams without direct authority
Strong project management skills and ability to meet timelines for data delivery
Hands-on laboratory experience with small or large molecule LC-MS bioanalytical methods/assays
Problem-solving, time management, organization, and follow-through skills
Familiarity with LIMS, eLNs, and instrument software
Proficient written and spoken English language skills
Legally authorized to be employed in the United States

Benefits

Comp & perks

Company bonus depending partly on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical, dental, vision, and prescription drug benefits
Healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Time off and leave of absence benefits
Employee assistance program
Fitness benefits
Employee clubs and activities