Indirizzo
Forma di lavoroAt 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.
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. The Materials Engineering team of DDCS provides value to the organization by providing materials selection and engineering support to Lilly’s existing and novel delivery device and packaging portfolio from advanced development through commercialization.
The Senior Director of Materials Engineering and Process Development is responsible for overseeing and managing all aspects of materials development/selection for delivery devices, biocompatibility assessments, developing novel process technologies (molding, welding, joining, assembly etc.) and lead the sustainability initiatives to support the current Lilly molecule portfolio in platform devices plus advance new delivery device platforms. This individual must be well versed in CM&C development, packaging and device development, materials development/selection and Process technologies to fulfill drug delivery needs in a sustainable and patient centric manner.
Responsibilities:
People Leadership, Business Administration, and Resource Planning
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 recruiting strategies and technical succession planning to develop technical talent.
Develop people and support diversity and inclusion. Ensure career development discussions, talent assessments and succession planning are in place for team-members. Drive overall functional area capabilities and skills to higher levels.
Responsible for overall technical soundness of materials development/selection and molding/welding/joining/assembly/process technologies.
Oversee resource, facility, expense, and capital planning through effective capacity forecasting models to ensure adequate resource for Lilly pipeline development.
Provide appropriate resources and oversight to ensure compliance with appropriate Quality, HSE, Sustainability and other Corporate Standards, policies, and procedures.
Delivery System Commercialization and Portfolio Delivery:
Identify and monitor disruptive materials and Process technologies to continuously improve our delivery and device portfolio.
Establish and leverage relationships with external partners to accelerate and access emerging packaging innovations, materials, molding and Process technologies.
Provide leadership in the development of advanced materials processing technologies, deep understanding of mechanics of materials and related computational analyses.
Ensure a robust understanding of key physical and chemical material properties and their interaction with the mechanical delivery device and their behavior in manufacturing, storage and use conditions.
Ensure thorough root cause analysis and problem solving of material related issues with product performance or manufacturing.
Ensure reliable on-time delivery of work products (regulatory modules, technical reports, qualification reports, development history reports, etc.).
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 device components and material selection as well as 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 MIH teams, IDM, IDAP, 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 Material Sciences/Engineering via deep and pertinent technical input.
Responsible for supporting 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 Qualification:
Ph.D. in Chemical Engineering, Material Science or relevant field and 7+ years of previous experience in pharmaceutical-science/medical devices/packaging
5+ years of team-lead or management experience.
OR
B.S. in Chemical Engineering, Material Science or relevant field with 15+ years of experience; or M.S. with 10+ years of experience in pharmaceutical-science/medical devices/packaging
5+ years of team-lead or management experience.
Additional Skills/Preferences
Medical Device Experience, Delivery Device Experience, Product Development experience.
Fundamental knowledge of regulated environment, including cGMP/laboratory requirements. Effective application of statistics and measurement uncertainty.
Measurement science knowledge & laboratory-based experience in evaluation of materials, delivery device systems; examples include materials selection/qualification, process technologies development, measurement techniques etc.
Fundamental understanding of surface science techniques, polymer testing methodologies, material compatibility evaluation, and the application of these to packaging and device projects. Previous thermal analysis, mechanical testing and materials characterization experience.
Demonstration of scientific, engineering, and laboratory leadership skills in an interdisciplinary team environment and demonstrated ability to lead cross-functional teams.
Strong communication and interpersonal skills and the ability to work productively in an interdisciplinary environment.
Demonstrated scientific, engineering, and applied cGMP skills preferred.
Additional Information:
Location: Indianapolis, IN
Travel is part of the job, usually 10-20% but up to ~30% at times.
Must be able to travel within US and OUS.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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