Principal Scientist (R3) – CRO Lab Qualification & Onboarding, Bioanalytical Outsourcing

Eli Lilly and Company; Boston (MA); Sur place; USD 69 000 - 196 000; Plein temps

Résumé du poste

Eli Lilly and Company in the United States is seeking a Principal Scientist to lead the qualification and onboarding of CRO partners for ADME and bioanalytical assays, providing scientific oversight and strategic guidance across discovery through clinical programs.

This high-visibility role requires deep bioanalytical expertise, mentoring, and strong cross-functional partnership with procurement, quality, and operations; travel about 25% is expected.

Qualifications

• Bachelor's degree in a scientific field with 7+ years bioanalytical lab experience or Master's with 5+ years.
• Experience in regulated bioanalytical labs including method development, validation, and/or sample analysis.
• Authorized to work in the United States on a full-time basis; Lilly will not sponsor visas.

Responsabilités

• Lead CRO qualification and onboarding for ADME and bioanalytical assays.
• Provide scientific oversight for non-regulated and regulated method development and analysis.
• Collaborate with Discovery, Non‑Clinical, Clinical, Procurement, Quality and Operations to align CRO capabilities.
• Establish and improve CRO qualification standards and processes.
• Build strategic relationships with internal customers and external vendors.
• Mentor scientists across the bioanalytical outsourcing network.

Connaissances

Bioanalytical laboratory experience

Method development

Validation

Regulatory compliance

Cross-functional collaboration

Mentoring

Formation

Bachelor's degree in a scientific field

Master's degree in a scientific field

Outils

LIMS

eLNs

Instrument software

Description du poste

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

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
• Experience in a regulated bioanalytical laboratory setting, including method development, validation, and/or sample analysis.
• 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.

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

• Travel Percentage: ~25%

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly

Qualified candidates must be legally authorized to be employed in the United States. #WeAreLilly

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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.