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Job Description
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
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, with responsibility for developing and qualifying analytical methods for characterization, release, and stability testing of drug substance and drug product across the genetic medicines portfolio, spanning early-phase IND-enabling studies through commercial BLA readiness. The successful candidate will have deep hands-on expertise in chromatographic and electrophoretic separations and will contribute to GMP analytical activities within a cross-functional CMC development environment.
Key Responsibilities:
Design, develop, optimize, and execute chromatographic separations methods including anion-exchange (AEX/IEX), size-exclusion chromatography (SEC), and ion-pairing reversed-phase HPLC (IP-RP-HPLC) for purity, integrity, and quality attribute assessment of genetic medicine drug substance and drug product. Develop and execute capillary electrophoresis methods (CE-SDS, cIEF) for size- and charge-based characterization of drug substance components. Develop, qualify, and validate robust analytical methods for the identification and quantitation of process-related residual impurities in support of product quality and regulatory requirements. Apply separations-based techniques to support DS and DP release, characterization, and stability programs across genetic medicine modalities. Troubleshoot chromatographic and electrophoretic method performance issues including resolution, peak shape, carryover, and reproducibility, and implement appropriate corrective strategies. Evaluate and implement fit-for-purpose separations technologies to advance the analytical control strategy for genetic medicine programs. 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 for genetic medicine and ATMP products. Contribute analytical data and technical content supporting stability study design and execution across DS and DP matrices. Ensure all analytical work is conducted in 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 with high scientific accuracy and clarity. Maintain rigorous electronic laboratory notebook (ELN) practices and documentation standards for all experimental records. 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 and interpret externally generated data packages. Maintain awareness of emerging analytical technologies, regulatory guidance updates, and industry best practices relevant to genetic medicine analytical development. Collaborate within cross-functional project teams including process development, quality, regulatory affairs, and clinical operations to deliver analytical support for clinical trials and regulatory submissions. Communicate analytical results, timelines, and technical challenges clearly to team members and project stakeholders in oral and written formats. Contribute to a positive, inclusive, and scientifically rigorous team culture; share technical knowledge and support the growth of colleagues.
Basic Qualifications:
Ph.D. in Molecular Biology, Biochemistry, Biology, or Analytical Chemistry; with 0-5+ years of relevant pharmaceutical or biotech industry experience; or M.S. in Molecular Biology, Biochemistry, Biology, or Analytical Chemistry; with 6+ years of relevant pharmaceutical or biotech industry experience; or B.S. in Molecular Biology, Biochemistry, Biology, or Analytical Chemistry; with 12+ years of relevant pharmaceutical or biotech industry experience. Demonstrated hands-on laboratory proficiency with
HPLC/UHPLC
platforms and chromatographic separations (AEX/IEX, SEC, IP-RP-HPLC) applied to biopharmaceutical drug substance or nucleic acid analytes in a pharmaceutical or biotech development context. Practical experience with capillary electrophoresis platforms (CE-SDS and/or cIEF) for biopharmaceutical characterization in a pharmaceutical or biotech development context. Experience with method development, optimization, and qualification/validation of separations-based methods in a pharmaceutical or biotech development context. 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 applying separations methods to genetic medicine or ATMP products, including viral vector purity profiling, empty/full capsid ratio assessment, or nucleic acid payload characterization. Familiarity with orthogonal characterization platforms such as flow cytometry or mass spectrometry for genetic medicine product analysis. Knowledge of FDA/EMA regulatory expectations for separations-based CQA testing in genetic medicine CMC submissions. Experience supporting analytical aspects of IND or BLA/MAA submissions, including contributing to Module 3 analytical sections. Experience with immunoassay platforms (ELISA, MSD, Gyrolab) for residual host cell protein or impurity testing. 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; ability to present complex technical information to multidisciplinary audiences. Demonstrated ability to manage multiple priorities and work productively in a fast-paced, collaborative team environment.
Additional Information:
Travel:
0 to 15% Potential exposure to chemicals, allergens, and loud noises. 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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $126,000 - $244,200 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. #WeAreLilly
