Advisor - Prefilled Syringe Platform Lead

Prefilled Syringe Platform Lead

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.

The Delivery, Device and Connected Solutions (DDCS) organization within Eli Lilly and Company supports the design, development, and commercialization of drug products and pharmaceutical delivery systems including medical devices and container closure systems.

We are seeking a Prefilled Syringe Platform Lead to be a key contributor within our parenteral packaging team, offering advanced technical expertise in the field of parenteral packaging and Lilly's combination products. This role demands established skillset and knowledge in parenteral packaging for drug products, working collaboratively with CMC, drug product development, device design, manufacturing and quality teams to ensure successful development and commercialization of Lilly drug products and devices.

• Lead selection, development, assessment and qualification of prefilled syringe container closure systems throughout Lilly's new drug product development cycle for commercialization.
• Collaborate with formulation and analytical chemistry partners to perform mechanistic research and develop a robust understanding of key physical and chemical properties of packaging materials and their interactions with drug products. Ensure container closure systems' safety, protection, compatibility, and functionality attributes meet drug product and drug substance's requirements.
• Apply scientific principles and problem-solving approaches to advance fundamental understanding of complex challenges and develop innovative packaging solutions that enable drug product safety and efficacy.
• Work with internal and external subject matter experts (SMEs) to evaluate and develop new test methods for container closure qualification and establish robust control strategies.
• Partner with parenteral filling SMEs, external component suppliers, CDMOs, and OEMs to design and implement de-risked, viable filling processes for parenteral packaging components supporting clinical trials and potential commercial manufacturing.
• Prepare and support technical documentation, including protocols and reports, for parenteral drug product process development.
• Ensure technical soundness and quality of regulatory submission packages, including comprehensive control strategies and supporting rationale.
• Collaborate with external suppliers to define specifications for packaging components and systems.
• Collaborate with data science SME to adopt and apply artificial intelligence technology to accelerate packaging development and risk mitigation solutions.
• Drive technology innovation by exploring, identifying, and delivering new solutions to the parenteral packaging network; evaluate and prioritize emerging technologies for current and future applications.
• Provide technical leadership for team, departmental, and corporate initiatives, including due diligence activities related to parenteral packaging solutions.
• Enhance Lilly's professional reputation and competitive advantage through presentations, external conferences, publications, and other professional engagements.

• Bachelor's degree in engineering, chemistry, materials science, packaging or related field with 10+ years of experience
• Experience with prefilled syringe container closure systems and primary/parenteral packaging for drug products
• Solid understanding of regulatory processes and guidelines relevant to GMP manufacturing, drug development
• Demonstrated ability to influence others, present technical information to a variety of audiences, and communicate effectively with internal and external partners

• Master's degree with 5+ years of experience, or Ph.D with 3+ years of experience
• Previous experience with additional various container closure system including vials and cartridges, combination products and drug delivery system in medical device or pharmaceutical industry
• Familiarity with Quality By Design (QbD) and ICH guidelines
• Experience working effectively with cross functional groups and a variety of stakeholders
• Previous parenteral packaging qualification experience
• Capable and driven to make decisions and work proactively.
• Desire and ability to work effectively and create operational efficiencies that make a positive impact on the team
• Interest in learning about and applying processes and innovative approaches to the…