Advisor

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.

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. Check out this exciting opportunity to join the team.

Key Objectives/Deliverables:

• Serves as key technical resource in development and qualification of packaging components and container closure systems for new drug products. Develops innovative and commercially implementable solutions to design problems that arise for the primary packaging components.
• Works closely with key stakeholders (internal and external to Lilly) such as formulation scientists, analytical development scientists, device engineers, and device and drug product manufacturing colleagues to deliver new drug products for commercialization
• Leads risk assessments to evaluate components, systems, suppliers, control strategy, and processes.
• Coaches and mentors co-workers and provides deep technical leadership /guidance for container closure systems and their associated devices.
• Leads and/or support technical transfer and/or technical due diligence activities for current and prospective packaging projects and prospective manufacturing sites.
• Authors and provides technical review of critical packaging documentation including technical protocols, reports, and regulatory submission content.
• Possesses and develops knowledge of compliance procedures in a product development environment and stays ahead of current packaging technology for use in product development, process development, and manufacturing.
• May represent department or company in interactions with internal and external committees or regulators, packaging component suppliers, contract manufacturer partners, presentations, publications or other professional activities.

Required Skills and Experience:

• Knowledge of and experience with development and qualification of container closure and packaging systems.
• Experience with container closure system development for sterile products.
• Experience with drug development.
• Proven scientific, engineering, and applied cGMP skills.
• Oral and written communication skills and experience, including technical report writing and regulatory document development.
• Problem solving and decision-making skills.
• Experience with technology transfer and due diligence inquiry.
• Knowledge of fundamental statistical concepts with the ability to apply them to process design, experimental design, and process/design optimization.
• Fundamental knowledge of risk analysis and risk analysis tools.

Basic Qualifications

• PhD degree in materials, polymer, chemical, or biomedical engineering OR a Masters Degree in relevant field with significant industrial experience (> 5 years).

Additional Information

• Travel is part of the job, usually 10-20%; must be able to travel within US and sometimes OUS.

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

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.