Advisor - Molecular Biology, Analytical Development - BR&D
Eli Lilly and Company
August 22, 2026
On-site
Indianapolis, IN
Clinical Research and Development
Position Overview
Advisor (BRD Analytical Development) supporting analytical development for genetic medicines and ATMPs. Primarily lab-based; develop/qualify analytical methods for drug substance and drug product quality attributes across the portfolio (from early IND-enabling through commercial BLA readiness) in a GMP CMC environment.
Key Responsibilities
- Develop, qualify, and execute PCR-based methods (qPCR, ddPCR/dPCR) for viral vector genome titration, residual DNA quantitation, and related nucleic acid analytes.
- Use immunoassay platforms (ELISA, MSD, Gyrolab) for residual host cell protein/impurity testing.
- Apply molecular biology techniques: 1-/2-D gel electrophoresis, blotting, restriction enzyme analysis.
- Contribute to analytical control strategies (CQAs and test methods).
- Support assay qualification/verification/validation per ICH Q2(R2) and regulatory expectations.
- Support stability study design/execution across DS/DP matrices.
- Ensure GMP/GLP and applicable HSE compliance; maintain ELN and documentation.
- Author/review methods, protocols, reports, method transfer packages, and technical summaries.
- Support method transfer to CRO/CMO and Lilly sites; participate in comparability studies.
- Provide technical input/review externally generated data; monitor emerging analytics/regulatory updates.
- Collaborate cross-functionally; communicate results/timelines/challenges.
Basic Qualifications
- PhD (0–5+ yrs) or MS (6+ yrs) or BS (12+ yrs) in Molecular Biology/Biochemistry/Biology/Analytical Chemistry.
- Proficiency with qPCR and/or ddPCR/dPCR.
- Proficiency with immunoassay platforms (ELISA/related).
- Hands-on molecular biology (gel electrophoresis, blotting, restriction analysis).
- Ability to design experiments, generate high-quality data, and interpret results.
- Familiarity with GMP/GLP.
Additional Skills & Preferences
- Viral vector (AAV, LVV) or cell therapy analytics (genome integrity, residual DNA, encapsidation efficiency).
- NGS workflows and bioinformatic interpretation.
- FDA/EMA expectations for nucleic-acid-based CQA testing; IND/BLA/MAA Module 3 experience.
- Method transfer and inter-lab comparability studies.
- ELN/data management (e.g., Benchling); strong oral/written communication.
Additional Information
- Travel: 0–15%; potential exposure to chemicals/allergens and loud noises.
- Anticipated wage: $126,000–$244,200; eligible for company bonus and comprehensive benefits (e.g., 401(k), medical/dental/vision, vacation, life/death benefits, time off/leave, well-being benefits) for eligible employees.
Application Instructions
- If you need an accommodation to submit a resume, complete Lilly’s workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
Advisor (BRD Analytical Development) supporting analytical development for genetic medicines and ATMPs. Primarily lab-based; develop/qualify analytical methods for drug substance and drug product quality attributes across the portfolio (from early IND-enabling through commercial BLA readiness) in a GMP CMC environment.
Key Responsibilities
- Develop, qualify, and execute PCR-based methods (qPCR, ddPCR/dPCR) for viral vector genome titration, residual DNA quantitation, and related nucleic acid analytes.
- Use immunoassay platforms (ELISA, MSD, Gyrolab) for residual host cell protein/impurity testing.
- Apply molecular biology techniques: 1-/2-D gel electrophoresis, blotting, restriction enzyme analysis.
- Contribute to analytical control strategies (CQAs and test methods).
- Support assay qualification/verification/validation per ICH Q2(R2) and regulatory expectations.
- Support stability study design/execution across DS/DP matrices.
- Ensure GMP/GLP and applicable HSE compliance; maintain ELN and documentation.
- Author/review methods, protocols, reports, method transfer packages, and technical summaries.
- Support method transfer to CRO/CMO and Lilly sites; participate in comparability studies.
- Provide technical input/review externally generated data; monitor emerging analytics/regulatory updates.
- Collaborate cross-functionally; communicate results/timelines/challenges.
Basic Qualifications
- PhD (0–5+ yrs) or MS (6+ yrs) or BS (12+ yrs) in Molecular Biology/Biochemistry/Biology/Analytical Chemistry.
- Proficiency with qPCR and/or ddPCR/dPCR.
- Proficiency with immunoassay platforms (ELISA/related).
- Hands-on molecular biology (gel electrophoresis, blotting, restriction analysis).
- Ability to design experiments, generate high-quality data, and interpret results.
- Familiarity with GMP/GLP.
Additional Skills & Preferences
- Viral vector (AAV, LVV) or cell therapy analytics (genome integrity, residual DNA, encapsidation efficiency).
- NGS workflows and bioinformatic interpretation.
- FDA/EMA expectations for nucleic-acid-based CQA testing; IND/BLA/MAA Module 3 experience.
- Method transfer and inter-lab comparability studies.
- ELN/data management (e.g., Benchling); strong oral/written communication.
Additional Information
- Travel: 0–15%; potential exposure to chemicals/allergens and loud noises.
- Anticipated wage: $126,000–$244,200; eligible for company bonus and comprehensive benefits (e.g., 401(k), medical/dental/vision, vacation, life/death benefits, time off/leave, well-being benefits) for eligible employees.
Application Instructions
- If you need an accommodation to submit a resume, complete Lilly’s workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation