Director/Sr. Director, 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 leader for our analytical development function. Reporting to the Associate VP of LNP Drug Product Development and Manufacturing, the ideal candidate will build and lead a diverse analytical development team within the Advanced Delivery Systems (ADS) organization to support development of next-generation RNA-LNP therapies as well as other drug delivery innovation efforts. The individual will partner closely with Lilly Genetic Medicines, Process and Formulation, Bioproduct Research and Development, Cell and Gene Therapy, and the broader Delivery Devices and Connected Solutions team to advance Lilly’s transformative pipeline. The successful candidate will combine deep scientific expertise, strategic leadership, operational excellence and a passion for tackling new challenges in a fast-paced, dynamic environment.

Key Responsibilities

• Establish vision and roadmap for analytical development functions, including innovative analytical platforms supporting RNA-LNP based genetic medicines and other drug delivery programs
• Provide organizational leadership aligned with company objectives.

• Recruit, mentor, and retain scientific talent, fostering the growth of a diverse, high-performing team.

• Partner with research, formulation, process, manufacturing, quality, and regulatory teams to define product CQAs, assess developability, evaluate assay readiness for technical transfer, and mitigate risks during scale-up.

• Lead development, optimization, pre-qualification of analytical methods, and build characterization, release, stability, and comparability testing programs for products in the advanced delivery systems pipeline.

• Keep abreast of emerging analytical technologies and drive innovative solutions to characterize RNA cargos, lipids, targeting moieties, and nanoparticles, addressing complex assay challenges in compliance with evolving regulatory expectations.

• Author and review technical reports and relevant sections of regulatory submissions. Participate in regulatory interactions as needed.

• Identify external collaborations to enhance internal capabilities and drive analytical innovation and represent the company at scientific meetings and industry forums.

Basic Qualifications

• PhD in biochemistry, analytical chemistry, molecular biology, or a related biological science, with 10+ years of relevant industry experience in assay development and 5+ years in a leadership role.
• Demonstrated success leading analytical development teams supporting advanced cell and gene therapeutics within matrixed, fast-paced, innovation-driven environments.
• Deep, hands-on experience in LC-MS and separation sciences (e.g., IP-RP, SEC, IEX, CGE, DLS, MALS) for characterizing the mRNA, protein, and lipid components of LNP-based products or extensive experience with bioassays (ELISA, flow cytometry, PCR, cell-based functional assays, and potency matrices).
• Proven experience in phase-appropriate assay development, optimization, qualification, and transfer for lot release, stability, and product characterization from early through late-stage development.

• Solid understanding of ICH guidelines and industry best practices for cell and gene therapies.

• Excellent communication, prioritization, and problem-solving skills, with the ability to influence scientific direction and drive scientific excellence across stakeholders.

Additional Skills and Preferences

• Prior experience authoring regulatory submission documents and supporting health authority interactions
• Ability to manage CDMOs and external collaborations to deliver quality results on 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

$168,000 - $264,000

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.

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