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Overview:
Lilly established the Delivery, Device and Connected Solutions (DDCS) for the purpose of crafting, developing, launching, and revolutionizing proprietary delivery device systems. This business is unique to the broader Lilly Research Labs organization due to its focus on patient centered delivery system solutions, its innovative approach to deliver platforms using both internal and external technologies, and its level of integration with the commercial groups and Business Units. The DDCS organization uses alliances in design and manufacturing to rapidly convert proprietary concepts into products that meet the users' needs and intended uses.
Position Summary:
DDCS is seeking a Senior Director, Packaging Systems to lead, support, and manage container closure and secondary packaging systems design, as well as packaging and shipping processes in support of Lilly clinical drug and delivery device pipeline portfolio. This individual must be versed in CMC development, materials evaluation, and packaging systems design and development to fulfill patient and drug delivery needs as well as drug formulation protection and compatibility requirements.
Responsibilities:
People Leadership, Business Administration, and Resource Planning
Set scientific direction and quality standards for the organization. Ensure technical soundness and reliable on-time delivery of work products (regulatory modules, technical reports, qualification reports, development history reports, etc.).
Align, manage and integrate packaging development projects with Lilly clinical assets and DDCS device initiatives. Oversee resource, facility, expense, and capital planning through effective capacity forecasting models to ensure adequate resource for Lilly pipeline development.
Lead and maintain a highly competitive cross-functional technical organization consisting of engineers and scientists of very diverse education/training backgrounds. Build and execute long range people recruiting, retention, and growth strategies and technical succession planning to develop technical talents.
Provide appropriate resources and oversight to ensure compliance with appropriate quality, HSE, and other corporate standards, policies, and procedures.
Delivery System Commercialization and Portfolio Delivery:
Guide integration of packaging system development with CMC and device development workstreams to influence and enable Lilly clinical asset development strategy.
Ensure container closure system control strategy and test methods are appropriately developed and qualified to inform design decision-making and enable control of device/containers/packaging performance.
Ensure adequate resourcing of CM&C teams, regulatory submission writing, test method support for engineering studies, investigations, and tech transfer activities.
Work closely with Business Units, Affiliates, and Manufacturing to ensure the appropriate qualification of primary packaging and device components and the successful tech transfer to manufacturing sites to enable commercial packaging and device control strategies.
Provide in-depth technical advice and guidance beyond department. Work with BR&D, SMDD, GQL and QC lab organizations to assess projects for design and process risks and use resources to mitigate those risks before they affect the project delivery timeline.
Internal and External Alliances / Advisory Boards:
Support corporate development and due-diligence activities that are relevant to Devices and Containers via deep and pertinent technical input.
Sponsor and support existing internal and external alliances and developing additional external alliances as the business and capability requirements evolve to drive value and on-time delivery.
Represent Lilly DDCS on external advisory boards and in relevant professional society activities.
Author, review, and approve technical reports and/or regulatory submissions. Respond to regulatory review questions. May serve as a representative of the department or company for industry regulators.
Enhance Lilly's professional image and competitive advantage through patents, presentations and other professional activities.
Basic Requirements:
PhD in chemistry, materials science, pharmaceutical science, or a related field, along with 7+ years of experience in pharmaceutical and medical device development. OR BS in chemistry, materials science, pharmaceutical science, or a related field with 10+ years of experience in pharmaceutical and medical device development.
3+ years in CMC development, materials evaluation, and packaging systems design required.
Proven experience leading a technical team.
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