Advisor - Prefilled Syringe Platform Lead

Position Overview

We are seeking a Prefilled Syringe Platform Lead to be a key contributor within our parenteral packaging team.

Key Responsibilities

• 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.

Basic Requirements

• 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.

Additional Preferences

• 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 parenteral packaging and drug development teams within the organization.