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.
Position Overview:
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.
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
Other Information
- Travel is part of the job, may be up to 10%; must be able to travel within US and at times, internationally.
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.
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