Advisor, Bioanalytical Chemistry

Eli Lilly and Company; Watertown (MA); On-site; USD 168,000 - 268,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Health, dental, vision benefits

Pension

Vacation benefits

Well-being programs

Job summary

Orna Therapeutics, Inc., a Lilly subsidiary in Watertown, MA, seeks an experienced scientist to lead LC-MS/MS bioanalytical method development and validation supporting PK and biomarker assessments across drug programs.

You will design IA-LC-MS/MS methods for large molecules, oversee sample analysis campaigns, and partner with CROs and discovery teams to ensure data quality and regulatory compliance. A PhD with 3+ years in industry is required.

Qualifications

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related scientific discipline with 3+ years of relevant industry experience
• Hands-on expertise with LC-MS/MS instrumentation for quantitative protein/peptide bioanalysis
• Experience with large molecule/biotherapeutic bioanalysis and regulatory guidance

Responsibilities

• Design, develop, and qualify LC-MS/MS methods for quantifying protein/peptide biomarkers and PK analytes in biological matrices (plasma, serum, tissue) per BMV guidance
• Lead strategy for IA-LC-MS/MS or hybrid LBA-LC-MS approaches for large-molecule analysis
• Oversee sample analysis campaigns supporting animal studies and troubleshoot matrix effects and assay robustness
• Author/review validation protocols, reports, and SOPs ensuring regulatory/compliance standards
• Serve as scientific contact for CRO partners, overseeing method transfer and data quality
• Collaborate with discovery teams for study design and data interpretation
• Present data and rationale in cross-functional settings
• Mentor junior scientists and contribute to training and process improvements

Skills

LC-MS/MS

Biomarker analysis

Analytical chemistry

Regulatory bioanalysis

Education

Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related

Tools

IA-LC-MS/MS

LBA-LC-MS

Job description

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.

Orna Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company, is an innovative biotechnology startup based in Watertown, MA, committed to developing groundbreaking therapies for diseases that current approaches cannot address. With our pioneering circular RNA technology, developed at MIT, we are at the forefront of advancing the next generation of RNA therapeutics. Our pioneering expression and delivery platform positions us to tackle complex diseases, including B cell-driven autoimmune disorders, B cell malignancies, sickle cell disease, and beyond.

We are seeking an experienced scientist with expertise in liquid chromatography-mass spectrometry (LC-MS/MS) to lead bioanalytical method development, validation, and sample analysis supporting pharmacokinetic (PK) and protein biomarker assessments across drug development programs. This role will contribute scientific and technical leadership to cross-functional teams supporting discovery studies, including biotherapeutics and novel modalities (e.g., LNP, RNA-based therapeutics).

Key Responsibilities

• Design, develop, and qualify LC-MS/MS methods for quantifying protein/peptide biomarkers and PK analytes in biological matrices (plasma, serum, tissue) in accordance with FDA/EMA Bioanalytical Method Validation (BMV) guidance
• Lead technical strategy for immunoaffinity-LC-MS/MS (IA-LC-MS/MS) or hybrid LBA-LC-MS approaches for large-molecule and biomarker analysis
• Oversee sample analysis campaigns supporting animal studies, including troubleshooting matrix effects, parallelism, and assay robustness issues
• Author and review method validation protocols, reports, and SOPs; ensure compliance with regulatory and quality standards
• Serve as scientific point of contact for CRO partners, overseeing method transfer, technical review, and data quality
• Collaborate with discovery teams to support study design and interpretation of bioanalytical data
• Present data and technical rationale in cross-functional settings
• Mentor junior scientists and contribute to department-level technical training and process improvement

Basic Qualifications

Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related scientific discipline with 3+ years of relevant industry experience

Additional Skills/Preferences

• Hands-on expertise with LC-MS/MS instrumentation (e.g., triple quadrupole, high-resolution MS) for quantitative protein/peptide bioanalysis
• Understanding of PK assay development principles and regulatory bioanalytical guidance (FDA 2018 BMV, EMA equivalents)
• Experience with large molecule/biotherapeutic bioanalysis (e.g., biomarker proteins, mAbs, fusion proteins, novel modalities)

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.

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.

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

$168,000 - $268,400

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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