As a Principal Scientist on our Bioanalytical Outsourcing team, you will take the lead in qualifying and onboarding new Contract Research Organization (CRO) laboratories, building the external network that powers Lilly's growing portfolio of small molecule, oligonucleotide, peptide, biologic, and gene therapy programs, and providing ongoing scientific oversight of CRO performance, data quality, and regulatory compliance after onboarding. This is a high-visibility role at the center of Lilly's expanding bioanalytical capabilities - you will shape how we select, evaluate, and integrate external partners, directly influencing the speed and quality of the data that advances medicines from discovery through the clinic. You will bring deep bioanalytical expertise and sound scientific judgment to a fast-paced, interdisciplinary team, mentoring colleagues and partnering across Discovery, Non-Clinical, Clinical, Procurement, Quality, and Operations. If you are energized by solving novel technical challenges, building lasting partnerships, and growing your career at the leading edge of bioanalytical science, we want to hear from you!
The bioanalytical outsourcing team supports all modalities including small molecules, oligonucleotides, peptides, biologics, and gene therapies across analytical platforms (e.g., ligand binding, LC-MS, PCR). Together, we ensure the delivery of the bioanalytical data needed to advance Lilly's growing portfolio - offering broad exposure across modalities and platforms as our pipeline continues to expand.
Responsibilities:
- Lead the qualification and onboarding of new CRO partners for ADME and bioanalytical (bioA) assays, serving as the primary scientific point of contact from initial technical assessment through successful integration.
- Provide independent scientific oversight and strategic guidance to CRO partners for non-regulated and regulated bioanalytical method development, validation, and sample analysis.
- Collaborate and influence cross-functionally with Discovery, Non-Clinical, and Clinical teams to align CRO capabilities with evolving program needs.
- Partner with Procurement, Quality, and Operations to establish and continuously improve CRO qualification standards and processes.
- Build and sustain strategic relationships with internal customers and external vendors, providing bioanalytical method support, troubleshooting, and critical reagent management.
- Mentor scientists and share technical expertise across the bioanalytical outsourcing network.
Minimum Qualification Requirements:
- Bachelor's degree in a scientific field (e.g., chemistry, biology, or pharmaceutical sciences) 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.
- Demonstrated hands-on experience in a regulated bioanalytical laboratory setting, including method development, validation, and/or sample analysis.
Additional Preferences:- Understanding of the current ICH M10 BMV guidance requirements and GLP/GCP regulations.
- Prior experience qualifying, onboarding, or providing scientific oversight to CRO or other outsourced laboratory partners.
- Experience with sponsor-vendor interactions and relationship building.
- Demonstrated ability to mentor scientists and influence cross-functional teams without direct authority.
- Strong project management, driving to meet timelines for data delivery.
- Hands-on laboratory experience with small or large molecule LC-MS bioanalytical methods/assays.
- Excellent problem-solving skills, time management, organization, and follows through on commitments.
- Familiarity with related systems and applications (LIMS, eLNs, instrument software).
- Proficient written and spoken English language skills including effective verbal communication.
Additional Information:Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$69,000 - $195,800
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.
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