Shipping and Distribution Development Engineer - DDCS

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!

DDCS is seeking a highly skilled and motivated Shipping and Distribution Development Engineer to join our team. In this role you will be responsible for leading regulatory submission enabling data to support the distribution of pharmaceutical products while ensuring compliance with regulatory standards and optimizing shipping processes to improve efficiency and reduce costs. A key focus of this role will be on rigorous testing and validation of shipping and distribution methods to ensure product integrity and safety.

Key Responsibilities:

• Study Development, Executing and Reporting: Plans and executes key activities for drug products and drug substances to support the distribution of new chemical entities and line extensions in accordance with internal quality system procedures. Leads or supports the authoring and technical review of documentation including protocols, technical reports, and regulatory submission documentation.
• Regulatory Compliance: Ensure all shipping and distribution activities comply with relevant Good Distribution Practice (GDP) regulatory requirements.
• Process Optimization: Analyze and improve shipping and distribution processes to enhance efficiency and minimize risks.
• Shipping and Distribution Testing: Develop and implement testing protocols to validate product integrity and safety of shipping and distribution methods, with a focus on ISTA and ASTM transportation standards. Write regulatory submission sections and respond to regulatory body questions regarding shipping and distribution.
• Data Analysis: Utilize data analytics to assess product stability trends.
• Documentation: Maintain accurate records of shipping and distribution development activities, including documentation required for regulatory compliance.
• Team Collaboration: Work closely with other departments (commercial manufacturing, drug product formulation, clinical trial planning, quality assurance, etc.) to ensure seamless operations and execution of deliverables needed to enable new product development and launch
• Quality Always Approach: Demonstrate engagement and employ a quality mindset in all endeavors by proactively identifying quality issues and communicating appropriately.

Basic Requirements: 

• Bachelor's degree in Engineering, Logistics, Supply Chain Management, or a related field.
• Minimum of 1 year of experience in pharmaceutical or regulated industry.

Additional Skills/Preferences:

• 5 or more years of experience in pharmaceutical or regulated industry
• Master’s degree in engineering or field associated with pharmaceutical development
• Submission writing experience and experience with working on CMC teams
• Proven understanding of GDP and GLP practices and regulations.
• Experience in developing and implementing testing protocols for shipping and distribution, with a focus on ISTA and ASTM transportation standards.
• Experience with writing regulatory submissions.
• Excellent analytical and problem-solving skills.
• Proficiency in data analysis tools.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Detail-oriented with a focus on accuracy and compliance.
• Successful interaction with senior technical engineering and scientific personnel.
• Experience working in a diverse networked technical organization with proven skills to manage suppliers and alliance partners.

Additional Information:

• Ability to travel up to 10% of the time both domestic and international.
• Role is an in-office (minimum of three days) position; this position is not open for being a remote role.

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