Advisor - Development Engineering - Drug-Device Combination Products (ddCS)

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.

Organization Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Overview

Delivery, Devices, and Connected Solutions (DDCS) sits within Eli Lilly's Product Research & Development organization. We are a diverse team of scientists and engineers responsible for discovering, designing, and developing patient-centric drug delivery solutions across a broad range of modalities — from injection devices to novel routes of administration and nanomedicines. DDCS drives the drug delivery innovation agenda across early and late development to meet the needs of an expanding portfolio that spans small molecules, biologics, and nucleic acid therapeutics.

DDCS is organized around a matrix model with strong disciplinary and functional horizontals supporting innovation and commercialization verticals. Our vision is to get our medicines to more patients faster by accelerating reach and scale, guided by three strategic pillars: Delivery Systems, Robust & Sustainable, and Patient Experience + Outcomes.

The Drug-Device Combination Product (ddCP) Development Engineering team is a critical horizontal capability within DDCS, responsible for bridging device platform expertise with CMC drug product development to enable seamless combination product submissions and launches across Lilly's innovation and commercialization verticals. This team integrates with DDCS device development functions, Regulatory, and PRD CMC scientists to ensure devices are appropriately selected, developed, and integrated with Lilly's clinical pipeline.

The Team Leader for Development Engineering – Drug-Device Combination Products (ddCP) plays a critical technical leadership role in applying Lilly's existing device platform to advance Lilly's combination product portfolio from early development through commercial launch. This position leads a multidisciplinary team of development engineers operating across the DDCS matrix, responsible for executing device deliverables, combination product design controls, regulatory submissions, and commercialization strategies.

Responsibilities:

Device Optionality & Deliverability Assessment

• Evaluate device technology platforms (auto-injectors, prefilled syringes, pen injectors, inhalers) and provide device selection recommendations for clinical pipeline assets.

• Conduct risk-benefit analyses of device options considering technical, regulatory, commercial, and supply chain factors.

• Lead drug deliverability assessments to inform device optionality decisions across patient needs, drug product characteristics, and technical feasibility.

• Develop technical strategies for device-drug integration that optimize product performance, manufacturability, and patient experience.

• Partner with Innovation and Device Development horizontal teams to assess emerging technologies applicable to pipeline molecules.

Combination Product Development Strategy & Execution

• Partner with CMC, Regulatory, and Clinical teams to develop comprehensive combination product clinical development plans, including device bridging strategies and regulatory pathway determination.

• Lead development of commercialization strategies for ddCP, ensuring alignment across technical, regulatory, commercial, and manufacturing stakeholders.

• Create and own device development plans encompassing design, testing, manufacturing process development, and validation activities.

• Oversee execution of development plans; manage program risks, dependencies, and issue resolution to ensure critical path milestones are met.

Design Controls & Clinical Supply Enablement

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