Director - Packaging System Solutions

Lilly Delivery, Device, And Connected Solutions

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. 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. 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.

Key Responsibilities and Deliverables

Develop risk-based packaging selection tool that leverages AI technology to significantly reduce risks. This tool aims to enhance our packaging processes by providing intelligent risk assessments and recommendations.

Lead scientific investigations to understand the interaction between CCS (Container Closure System) and drug products and gain mechanistic insights into how these interactions can significantly impact on the quality and efficacy of our drug products.

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.

Develop container closure strategy to ensure suitable packaging systems and delivery devices to mitigate risks in clinical studies and commercialization of new drug products development, achieving desirable clinical and business outcomes.

Support device optionality assessments to inform delivery decisions in close collaboration with cross-functional groups, such as device design, human factors, secondary packaging, distribution and shipping, and drug development teams.

Possibly manage and lead a team of packaging engineers and ensure quality deliveries within areas of responsibility are completed effectively and on time to support the pipeline.

Provide mentorship and develop junior engineers.

Provide technical leadership and support in selecting, developing, and qualifying and tech transfer of packaging solutions throughout Lilly's new drug product development cycle for commercialization.

Accountable for technical soundness and quality of submission data package, robust control strategy, and associated rationale development.

Lead critical packaging development activities, including risk assessment, component and system qualification, and packaging suitability assessment. Author and deliver high-quality technical protocols and reports. Collaborate with CMC and regulatory groups to support submissions and address agency questions and requirements.

Work with external suppliers to develop specification of packaging components and systems.

Work with both internal and external manufacturing teams to ensure appropriate qualifications of packaging components and systems, as well as successful transfer to manufacturing sites to enable commercial packaging and control strategies.

Support the exploration, identification, and delivery of technology to the packaging network. Profile and prioritize new technologies against current and future applications.

Support team, department, and corporate initiatives and due-diligence activities relevant to packaging solutions through deep and pertinent technical input.

Enhance Lilly's professional image and competitive advantage through presentations, external conferences, publications, and other professional activities.

Basic Qualifications

PhD degree in Materials Engineering, Chemical Engineering, Biomedical Engineering, or relevant field with 15+ years of combined experience in materials, pharmaceutical science, or medical device industry.

Additional Skills / Preferences

Strong computational skills

Previous experience with combination products, drug delivery devices, container closure systems and primary packaging

Familiarity with Quality By Design (QbD) and ICH guidelines

Experience in working effectively with cross functional groups

Solid understanding of basic requirements of regulatory agencies

Previous packaging qualification experience

Demonstrated ability to influence and operate cross-functionally

Coach and mentor junior engineers

Additional Information

Ability to travel required and may be up to 10%. Must be able to travel within the US and sometimes outside of the US. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include : Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $142,500 - $253,000. 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.