Advisor - Molecular Biology, Analytical Development - BR&D
Eli Lilly and Company
June 30, 2026
On-site
Indianapolis, IN
Clinical Research and Development
Position Overview
- Advisor to support analytical development for genetic medicines and advanced therapy medicinal products (ATMPs). Primarily laboratory-based; develop and qualify analytical methods for DS/DP quality attributes across the genetic medicines portfolio (IND-enabling through commercial BLA readiness) in a GMP CMC environment.
Key Responsibilities
- Develop, qualify, execute PCR-based assays (qPCR, ddPCR/dPCR) for viral vector genome titration, residual DNA, and related nucleic acid analytes.
- Use immunoassay platforms (ELISA, MSD, Gyrolab) for residual host cell protein/impurity testing.
- Apply molecular biology techniques (1D/2D gel electrophoresis, blotting, restriction enzyme analysis) for product characterization.
- Contribute to analytical control strategies and CQA/test method identification.
- Support assay qualification/verification/validation per ICH Q2(R2).
- Support stability study design/execution across DS/DP matrices.
- Author/review methods, protocols, reports, transfer packages, and summaries; maintain ELN/documentation.
- Support method transfer to CRO/CMO and Lilly sites; provide technical input and review external data.
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; immunoassays (ELISA/related);
- Hands-on gel electrophoresis, blotting, restriction analysis; independent experimental design and data interpretation; familiarity with GMP/GLP.
Additional Skills/Preferences
- Viral vector/cell therapy (AAV/LVV), genome integrity/residual DNA/encapsidation efficiency; NGS workflows; FDA/EMA nucleic-acid CQA knowledge; IND/BLA/MAA Module 3 experience; method transfer/inter-lab comparability; Benchling/data systems; strong technical communication.
Additional Information/Benefits (if eligible)
- Travel: 0–15%. Potential exposure to chemicals/allergens/loud noises.
- Potential bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible spending, life insurance, time off/leave, and well-being benefits.
- Advisor to support analytical development for genetic medicines and advanced therapy medicinal products (ATMPs). Primarily laboratory-based; develop and qualify analytical methods for DS/DP quality attributes across the genetic medicines portfolio (IND-enabling through commercial BLA readiness) in a GMP CMC environment.
Key Responsibilities
- Develop, qualify, execute PCR-based assays (qPCR, ddPCR/dPCR) for viral vector genome titration, residual DNA, and related nucleic acid analytes.
- Use immunoassay platforms (ELISA, MSD, Gyrolab) for residual host cell protein/impurity testing.
- Apply molecular biology techniques (1D/2D gel electrophoresis, blotting, restriction enzyme analysis) for product characterization.
- Contribute to analytical control strategies and CQA/test method identification.
- Support assay qualification/verification/validation per ICH Q2(R2).
- Support stability study design/execution across DS/DP matrices.
- Author/review methods, protocols, reports, transfer packages, and summaries; maintain ELN/documentation.
- Support method transfer to CRO/CMO and Lilly sites; provide technical input and review external data.
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; immunoassays (ELISA/related);
- Hands-on gel electrophoresis, blotting, restriction analysis; independent experimental design and data interpretation; familiarity with GMP/GLP.
Additional Skills/Preferences
- Viral vector/cell therapy (AAV/LVV), genome integrity/residual DNA/encapsidation efficiency; NGS workflows; FDA/EMA nucleic-acid CQA knowledge; IND/BLA/MAA Module 3 experience; method transfer/inter-lab comparability; Benchling/data systems; strong technical communication.
Additional Information/Benefits (if eligible)
- Travel: 0–15%. Potential exposure to chemicals/allergens/loud noises.
- Potential bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible spending, life insurance, time off/leave, and well-being benefits.