Advisor - Molecular Biology, Analytical Development - BR&D

Position Overview The BRD Analytical Development team is seeking an Advisor to support analytical development for genetic medicines and advanced therapy medicinal products (ATMPs). This role is primarily laboratory‑based and involves developing, qualifying, and executing PCR‑based methods, immunoassay platforms, and molecular biology techniques for drug substance and drug product quality attributes across the genetic medicines portfolio, from early‑phase IND‑enabling studies through commercial BLA readiness. The candidate will contribute to GMP analytical activities within a cross‑functional CMC development 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. Apply immunoassay platforms (ELISA, MSD, Gyrolab) for residual host cell protein or impurity testing. Perform molecular biology techniques including 1‑ and 2‑D gel electrophoresis, blotting, and restriction enzyme analysis for product characterization. Contribute to analytical control strategies for genetic medicine drug substance and drug product, including identification of critical quality attributes (CQAs) and appropriate test methods. Support assay qualification, verification, and validation activities per ICH Q2(R2) and applicable regulatory expectations. Contribute analytical data and technical content supporting stability study design and execution across DS and DP matrices. Ensure compliance with GMP, GLP, and applicable HSE requirements; maintain awareness of internal quality procedures and regulatory expectations. Author and review analytical methods, protocols, qualification/validation reports, method transfer packages, and technical summaries. Maintain rigorous electronic laboratory notebook (ELN) practices and documentation standards. Support technology transfer of analytical methods to CRO/CMO partners and Lilly manufacturing sites; participate in cross‑site qualification or co‑validation studies. Provide technical input during interactions with external analytical partners; review externally generated data packages. Maintain awareness of emerging analytical technologies, regulatory guidance updates, and industry best practices related to genetic medicine analytical development. Collaborate within cross‑functional project teams and communicate analytical results, timelines, and technical challenges clearly to stakeholders. Contribute to a positive, inclusive, and scientifically rigorous team culture; share technical knowledge and support colleague growth. Basic Qualifications Ph.D. in Molecular Biology, Biochemistry, Biology, or Analytical Chemistry; 0‑5+ years of relevant industry experience. M.S. in the same fields; 6+ years of relevant industry experience. B.S. in the same fields; 12+ years of relevant industry experience. Practical proficiency with qPCR and/or ddPCR/dPCR for quantitative nucleic acid analysis in a pharmaceutical or biopharmaceutical context. Practical proficiency with immunoassay platforms (ELISA or related technologies) for quantitative analysis of process‐related impurities or product quality attributes. Hands‑on experience with gel electrophoresis, blotting, restriction analysis applied to biopharmaceutical or genetic medicine characterization. Demonstrated ability to independently design experiments, generate high‑quality data, and interpret results in a development environment. Familiarity with GMP/GLP requirements and their application to analytical method development and documentation. Additional Skills & Preferences Experience with viral vector (AAV, LVV) or cell therapy analytical programs, including genome integrity, residual DNA, and encapsidation efficiency assessments. Familiarity with NGS workflows (library preparation, sequencing, bioinformatic interpretation) as an orthogonal characterization approach. Knowledge of FDA/EMA regulatory expectations for nucleic acid‑based CQA testing in genetic medicine CMC submissions. Experience supporting IND or BLA/MAA submissions, including analytic sections of Module3. Experience with method transfer to external CRO/CMO organizations and participation in inter‑laboratory comparability studies. Proficiency with electronic laboratory notebooks (e.g., Benchling) and data management systems. Effective oral and written communication skills for presenting complex technical information to multidisciplinary audiences. Ability to manage multiple priorities and work productively in a fast‑paced, collaborative team environment. Travel 0 to 15%. Accommodation Lilly is dedicated to helping individuals with disabilities actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form available on the Lilly Careers site. This request is part of the application process and further correspondence will not receive a response. Equal Employment Opportunity Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, colour, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Compensation and Benefits Actual compensation depends on education, experience, skills, and geographic location. The anticipated wage range is $126,000 – $244,200. Full‑time employees are eligible for a company bonus dependent on company and individual performance. Lilly offers a comprehensive benefit program including 401(k) participation, pension, vacation benefits, medical, dental, vision, prescription drug coverage, flexible benefits, life insurance, leave of absence benefits, and well‑being benefits such as employee assistance programs and fitness resources. #J-18808-Ljbffr 100 Eli Lilly and Company