Senior Advisor, Separation Science — Analytical Development

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 

Position Summary

We are seeking an accomplished Senior Advisor, Separation Sciences to provide scientific leadership for analytical development (AD) supporting next-generation mRNA-LNP-based in vivo CAR-T therapies within the Advanced Delivery Systems (ADS) organization. This individual will lead all chemistry assay effort, spanning multiple separation platforms, and serve as the technical SME for characterization and stability testing of the mRNA, protein, and lipid components of LNP-based drug substance/product.

The successful candidate will combine deep, hands-on separations expertise with strategic leadership, partnering closely with Lilly Genetic Medicines, Process and Formulation, Cell and Gene Therapy, and Quality teams to drive phase-appropriate analytical strategies and assay execution. The successful candidate will be self-motivated, independent, have hands-on bench skills, and able to lead and develop other scientist.

Key Responsibilities

• Serve as the technical lead and group leader for the separation science function within Analytical Development, defining and executing chemistry assay strategy and roadmap for RNA-LNP-based programs.

• Lead end-to-end development, optimization, pre-qualification, and technical transfer of chemistry assays across separation platforms (e.g., IP-UPLC, RP-UPLC, CGE, LC-MS, SEC, SEC-MALS, IEX) to characterize and quantify mRNA, protein, and lipid components of drug product.

• Represent the separation science function on cross-functional project teams and in technical review settings, and act as the primary analytical SME.

• Ensure assay data, methods, and practices comply with ICH guidelines and industry best practices for cell and gene therapies.

• Design, develop, and execute stability-indicating methods and forced-degradation studies to support product characterization, shelf-life determination, and ongoing stability programs.

• Establish assay comparability and bridging strategies across process/formulation changes, scale-up, and method transfers; apply sound statistical design (e.g., DOE) to reduce variability and improve assay robustness.

• Partner closely with cross-functional stakeholders to ensure integrated, phase-appropriate analytical strategies, define CQAs, and assess assay suitability and readiness for the transition from research through development to manufacturing.

• Manage external collaborations to enhance internal capabilities and drive analytical innovation.
• Evaluate and implement innovative separation science technologies and platforms to address emerging scientific and regulatory challenges.

• Author and review assay protocols, technical reports, and relevant sections of regulatory submissions.

Basic Qualifications

• PhD or MS in chemistry, biochemistry, or a related scientific discipline with 4+ years (PhD) or 10+ years (MS) of industry experience in separation science/chemistry assay development.

• Extensive, hands-on experience developing, optimizing, qualifying, and validating chemistry assays across multiple separation platforms (e.g., IP-UPLC, RP-UPLC, CGE, LC-MS, SEC, SEC-MALS, IEX).

• Demonstrated hands-on experience characterizing mRNA, protein, and/or lipid components using these platforms.

• Knowledge of ICH/FDA guidelines and industry best practices related to analytical methods for cell and gene therapies.

• Proven experience defining and executing phase-appropriate assay strategies, including stability program design and method transfer.

Additional Skills and Preferences

• Prior experience characterizing RNA-LNP based genetic medicines, process- and product-related impurities.

• Experience with LC-MS-based characterization of proteins, lipids, and/or oligonucleotides.

• Experience authoring regulatory submission sections and supporting health authority interactions.

• Strong critical thinking, communication, and problem-solving skills, with an ability to influence scientific direction and deliver in a matrixed, fast-paced environment.

• Ability to manage external collaborations and deliver quality results within a stringent timeline.

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$141,000 - $231,000

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