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

Role Summary

Advisor - Development Engineering for Drug-Device Combination Products (ddCP) leads a multidisciplinary team of development engineers to advance Lilly's drug-device combination portfolio from early development through commercial launch. The role applies device platform expertise to enable seamless integration with drug product development, overseeing device deliverables, design controls, regulatory submissions, and commercialization strategies within the DDCS matrix. Collaboration across CMC, Regulatory, Clinical, and Manufacturing teams ensures appropriate device selection, development, and integration with Lilly's clinical pipeline.

Responsibilities

• Device Optionality & Deliverability Assessment - Evaluate device platforms (auto-injectors, prefilled syringes, pen injectors, inhalers); provide device selection recommendations; conduct risk-benefit analyses; lead drug deliverability assessments; develop strategies for device-drug integration; partner with Innovation and Device Development 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; create and own device development plans; oversee execution and manage risks to meet critical path milestones.
• Design Controls & Clinical Supply Enablement - Oversee creation and maintenance of Design History Files (DHF) to ensure completeness for clinical trial material release and regulatory submissions; leverage existing device platforms to streamline device deliverables; own molecule-specific design control deliverables (PHA, user needs, design requirements, traceability); enable clinical batch release by ensuring device and combination product meet release specifications; provide technical guidance for clinical supply manufacturing.
• Integrated Combination Product Control Strategy - Develop and implement integrated control strategies for device specifications, process controls, and product performance attributes; partner with CMC to establish release and stability testing strategies; design stability studies per ICH guidelines; coordinate with commercial manufacturing organizations for technology transfer and inform control strategy.
• Regulatory Submissions & Agency Interactions - Lead technical content development for NBOp and marketing application 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; support inspections with technical documentation.
• Team Leadership & Organizational Development - Build, lead, and mentor a high-performing team of development engineers; provide career development guidance and performance reviews; develop and maintain SOPs, work instructions, and technical standards; recruit and onboard new talent to support portfolio growth; promote training and knowledge sharing.
• Cross-Functional Matrix Leadership - Serve as technical authority for device and combination product development across DDCS and PRD; build partnerships with Device Development, CMC, Clinical Development, Regulatory Affairs, Quality, Manufacturing, and Commercial; influence decisions on device platform selection and investment priorities; represent DDCS in governance forums and portfolio reviews; contribute to industry standards externally.

Qualifications

• Required: Bachelor's degree in Engineering (Mechanical, Biomedical, Chemical, Materials Science), Pharmaceutical Sciences, or related technical discipline
• Required: 13+ years of progressive experience in pharmaceutical/biotechnology product development, medical device development, or combination product development
• Required: 3+ years of team leadership experience
• Required: Demonstrated experience leading drug-device combination product development from early stage through regulatory approval
• Required: Exceptional written and verbal communication to diverse audiences
• Required: Risk management and problem-solving in ambiguous, complex technical situations
• Required: Quality and compliance mindset across GMP/GxP, design controls, and regulatory submissions
• Preferred: Advanced degree (MS, PhD) in a related technical discipline, with 10+ years of progressive experience (including 3+ years of team leadership)
• Preferred: Proficiency with device design controls and quality systems (FDA 21 CFR Part 820, ISO 13485) and drug CMC development processes
• Preferred: Experience with technology transfer and manufacturing scale-up for devices or combination products
• Preferred: Track record of leading cross-functional development teams in matrix organizations
• Preferred: Experience managing external partners, device suppliers, and contract manufacturers
• Preferred: Familiarity with combination product regulatory pathways, CDER/CBER coordination, and global requirements (FDA, EMA, PMDA, NMPA)
• Preferred: Strategic and commercial acumen: connecting technical decisions to portfolio and business outcomes

Education

• Bachelor's degree in Engineering (Mechanical, Biomedical, Chemical, Materials Science), Pharmaceutical Sciences, or related technical discipline

Additional Requirements

• Travel: 10–20%
• Location: Indianapolis, IN; Lilly Technology Center – North (LTC-N)