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

Eli Lilly and Company • Indianapolis, IN

1d • Onsite

About The Position

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.

Requirements

• Bachelor's degree in Engineering (Mechanical, Biomedical, Chemical, Materials Science), Pharmaceutical Sciences, or related technical discipline
• 13+ years of progressive experience in pharmaceutical/biotechnology product development, medical device development, or combination product development
• 3+ years of team leadership experience
• Demonstrated experience leading drug-device combination product development from early stage through regulatory approval.
• Exceptional written and verbal communication to diverse audiences from technicians to executives
• Risk management and problem-solving in ambiguous, complex technical situations
• Quality and compliance mindset across GMP/GxP, design controls, and regulatory submissions

Nice To Haves

• Advanced degree (MS, PhD) in a related technical discipline, with 10+ years of progressive experience as listed above (including 3+ years of team leadership experience)
• Proficiency with device design controls and quality systems (FDA 21 CFR Part 820, ISO 13485) and drug CMC development processes.
• Experience with technology transfer and manufacturing scale-up for devices or combination products.
• Track record of leading cross-functional development teams in matrix organizations.
• Experience managing external partners, device suppliers, and contract manufacturers.
• Familiarity with combination product regulatory pathways, CDER/CBER coordination, and global requirements (FDA, EMA, PMDA, NMPA).
• Strategic and commercial acumen: connecting technical decisions to portfolio and business outcomes

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 Oversee creation and maintenance of Design History Files (DHF) to ensure completeness and adequacy for clinical trial material release and regulatory submissions. Leverage existing device platforms to streamline device deliverables and accelerate development timelines. Own molecule-specific design control deliverables: risk assessments (PHA), design inputs (user needs, design requirements), and traceability to verified/validated design outputs. Enable clinical batch release by ensuring device and combination product meet release specifications; provide technical guidance and troubleshooting for clinical supply manufacturing.
• Integrated Combination Product Control Strategy Develop and implement integrated control strategies encompassing device specifications, process controls, and combination product performance attributes. Partner with CMC teams to establish combination product release and stability testing strategies. Design stability studies generating data packages supporting shelf-life and storage condition claims aligned with ICH guidelines. Partner with commercial manufacturing organizations to enable technology transfer activities; inform commercial control strategy.
• Regulatory Submissions & Agency Interactions Lead technical content development for NBOp and marketing application regulatory submissions (BLA, NDA, MAA). Author and review CMC sections related to device and combination product. Prepare technical briefing documents for regulatory meetings; respond to regulatory questions and deficiencies. Support regulatory inspections by providing technical expertise and documentation.
• Team Leadership & Organizational Development Build, lead, and mentor a high-performing team of development engineers; foster a culture of technical excellence, innovation, and continuous improvement. Provide career development guidance and conduct performance reviews with clear objectives and ongoing feedback. Develop and maintain SOPs, work instructions, and technical standards for combination product development engineering. Recruit and onboard new talent to support portfolio growth; build capability through training, knowledge sharing, and process standardization.
• Cross-Functional Matrix Leadership Serve as technical authority for device and combination product development across DDCS and PRD. Build strong partnerships with Device Development, CMC functions, Clinical Development, Regulatory Affairs, Quality, Manufacturing, and Commercial teams. Influence organizational decision-making on device platform selection, device optionality, and investment priorities across the DDCS matrix. Represent DDCS in governance forums, portfolio reviews, and leadership meetings. Contribute to industry standards development (ISO, ASTM, PDA) and share technical insights externally.

Benefits

• Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.
• The anticipated wage for this position is $126,000 - $204,600
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level