Advisor, Bioanalytical Chemistry
Eli Lilly and Company
Summary
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.
Job description
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)
Requirements
- Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related scientific discipline
- 3+ years of relevant industry experience
- 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)
Benefits
- 401(k) Matching
- Pension
- Vacation Benefits
- Medical, Dental & Vision
- Prescription Drug Benefits
- Flexible Spending Accounts
- Life Insurance
- Death Benefits
- Employee Assistance Program
- Fitness Benefits
- Company Bonus
Company overview
Eli Lilly and Company, commonly known as Lilly, is a leading American multinational pharmaceutical corporation headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company has grown into one of the world's most valuable pharmaceutical enterprises, with operations in approximately 125 countries. Lilly specializes in developing and manufacturing innovative medicines across multiple therapeutic areas, including diabetes, oncology, neuroscience, immunology, and cardiometabolic diseases. The company is renowned for its groundbreaking work in insulin production, having been the first to mass-produce insulin and later developing the first commercially available insulin product in the U.S. Lilly's current portfolio includes blockbuster medications such as Mounjaro and Zepbound (tirzepatide) for diabetes and obesity, Trulicity (dulaglutide) for type 2 diabetes, Verzenio (abemaciclib) for breast cancer, and Taltz (ixekizumab) for autoimmune conditions. With approximately 47,000 employees worldwide, Lilly maintains a strong commitment to research and development, investing heavily in scientific innovation to address some of the world's most significant health challenges. The company operates with a mission to make life better for people around the world through the discovery and delivery of innovative medicines.