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Sr. Advisor - Materials Engineering

Employer
Eli Lilly and Company
Location
Indianapolis, Indiana
Start date
Apr 4, 2024

Job Details

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.

In 1992, Eli Lilly and Company established the delivery device business for the purpose of designing, developing, launching and continuously improving proprietary delivery device systems. This business is unique to the broader Lilly Research Labs (LRL) organization due to its focus on patient-centered delivery system solutions, its new way to design and develop delivery platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. The Delivery Device Connect Solutions (DDCS) organization capitalizes on many alliances in design and manufacturing to rapidly convert proprietary product concepts into products that meet the users’ needs and intended uses. This business enables almost $4.0 billion in pharmaceutical sales and is projected to double in the next 6 years.

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 container closure systems and medical devices. The DDCS Material Engineering and Process Development Team provides value to the organization by providing materials selection and engineering support to Lilly’s existing and novel delivery device and packaging portfolio from early innovation through development and commercialization.

As a Materials Senior Advisor / Director, you will play a crucial role in research and development, focusing on Surface Science, Polymer Chemistry, Material of Concerns, and Biocompatibility. You will collaborate with cross-functional teams to select, analyze and inform risks and carry out risk mitigation plans for materials for medical devices applications. You will contribute to the materials development and launch efforts of Lilly’s medical devices with the following responsibilities:

  • Lead material selection for mechanical and electromechanical drug delivery devices from innovation through development and commercialization to achieve optimal solutions that satisfy cost and technical requirements.   Work with suppliers to maintain a network of key material options as well as testing capabilities to characterize materials. Participate in failure analysis and root cause investigations.

  • Support and lead biocompatibility assessments and reports writing including coordinating and interfacing with vendors. Possess solid understanding of current drug delivery device biocompatibility standards (such as ISO 10993, USP <87> and <88>) and be current with evolving regulations in the US, Japan, and EU (MDR, REACH etc.).

  • Support the authoring and technical review of material selection including biocompatibility and materials assessment per FDA, EU MDR and other global regulatory or notified body requirements.

  • Conduct research on surface properties, interactions, and modifications, and help R&D teams in understanding critical issues at the interface of materials and drug products.

  • Possess knowledge of REACH, RoHS requirements and evolving regulations and stay abreast of the evolution of chemical of concerns, and partner with global HSE teams to propose short-term and long-term strategies to address potential issues, for both container closure systems and medical devices.

  • Develop technically sound protocols, reports, regulatory summaries, and verification of methods and results in collaboration with business partners, global manufacturing sites, test laboratories and suppliers.

  • Communicate technical expertise and learnings at external conferences as well as to internal project teams and Lilly senior leadership at various cross-functional forums.

  • Ensure that work activities are conducted in accordance with applicable medical device regulations.

  • Follow cGMPs and ensure documentation is developed that supports decisions and changes to advance the Lilly molecule and drug delivery devices portfolio.

Minimum Requirements:

  • Ph.D. in Chemistry, Materials, Biochemistry, Engineering or other relevant fields with 3+ years of experience (or Masters degree in these fields with 10+ years of experience).

  • At least 2 years of experience in biocompatibility, surface science, chemicals of concern or polymer chemistry in pharmaceutical, medical devices or other highly regulated industries (e.g., Aerospace etc.) either as a direct employee or as a supplier/service provider to the pharmaceutical or medical devices industry.

Additional Skills and Preferences:

  • Expertise in material and polymer chemistry, polymerization techniques, and material synthesis.

  • Experience in polymer analysis (thermal methods, chemical methods, mechanical methods, rheological methods, surface analysis) and structure-processing-property relationships.

  • Knowledge of biocompatibility testing standards (e.g., ISO 10993, USP <87> or <88> etc.) and other relevant regulations (e.g., related to PFAS, Phthalates, REACH, RoHS etc.) as it applies to drug delivery devices.

  • GLP experience in the biocompatibility or material of concerns.

  • Strong background in surface science or prior experience in applied research, pharmaceutical product development.

  • Excellent problem-solving skills and attention to detail.

  • Effective communication and teamwork abilities.

  • Strong critical thinking skills with the ability to solve complex problems.

  • Experience with biomaterials, medical devices, or drug delivery systems.

  • Publications in relevant scientific journals.

  • Familiarity with global regulatory requirements as it relates to drug delivery devices.

Additional Information:

  • Position Location: Indianapolis, IN Lilly Technology Center-North (will consider remote employment for highly qualified candidates with an expectation to travel to Indianapolis for important meetings)

  • Travel 10% both 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.

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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