Lilly Assoc Sr Cnslt Engineer-DDCS in Indianapolis, Indiana
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 35,000 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.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
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 packaging systems.
The Packaging Systems Team in DDCS owns the development and qualification of drug substance and drug product packaging components and container closure systems. The Container Closure Engineer (CCE) leads the execution and documentation of packaging deliverables within a cross-functional CM&C team environment supporting each molecule-specific project in development for new chemical / biologic entities and line extensions. The CCE works closely with other functional areas including Project Management, Formulation, Analytical, Clinical Operations, Commercial Manufacturing, Regulatory, Quality, Materials Management, Human Factors, Systems Engineering, Device Design Engineering and Secondary Packaging to enable project progression. Key deliverables for the CCE includes container closure selection (primary and critical secondary packaging), suitability evaluation to enable use of packaging components in clinical trials, and the execution of studies and documentation to enable successful pharmaceutical product regulatory submissions.
The Container Closure Engineer will contribute to the development and launch of pharmaceutical products with the following responsibilities:
Packaging Engineering in Support of Clinical Portfolio CMC Development
Partner with key stakeholders (internal and external to Lilly) to enable project progression from clinical development through commercialization. Design, develop, and qualify container closure systems (CCS) to enable clinical studies and commercial drug product/combination product development. Develop the CMC data packages to justify and demonstrate CCS suitability.
Represents DDCS in CMC team, internal/external meetings to communicate and influence packaging strategy, component / system properties, risks, timing, and cost. Leads risk assessments to evaluate components, systems, suppliers, and processes.
Partner with Extractables / Leachables and Toxicology colleagues to obtain safety assessments for packaging materials.
Plan and execute key activities to support packaging design, selection, characterization testing, and system qualification for molecule-specific projects in accordance with quality system procedures and business practices.
Lead and/or support technical transfer and/or technical due diligence activities for current and prospective packaging projects and prospective manufacturing sites.
Lead the authoring and technical review of critical packaging documentation including technical reports, regulatory submission documentation, container closure system suitability assessments, and development history reports.
Syringe and Parenteral Packaging Technical Leadership
Provides technical leadership, strategy development, and serves as a key technical resource for container closure systems, and drug product/combination product development.
Presents DDCS deliverables and strategy during technical reviews and proactively shares technical information related to project work during internal seminars, forums, and poster sessions.
May represent department or company in interactions with internal/external committees, regulators, conference presentations, publications, or other professional activities.
Coaches and mentors others and provides deep technical advice for container closure systems and their applications with associated devices and processes
Parenteral Packaging Innovation and Development
Stay abreast of regulatory and compendial requirements for packaging components and systems and aims to influence future compendial changes through external committees (where appropriate).
Designs and leads studies to develop innovative packaging solutions, to de-risk drug product / container closure interactions to enable molecule project delivery and enhance Lilly’s competitive advantage through development of proprietary knowledge.
Ensure individual and departmental compliance with the laws, regulations, guidelines, procedures, and practices governing drug research and development, including the departmental and corporate standard operating, good manufacturing, and safety procedures.
Ensure that people and their environment are safe and that company policies concerning safety and confidentiality are followed.
- PhD in Engineering, Pharmaceutical Science, Materials Science, or Packaging (or related fields) and/or BS degree in relevant field with 15yrs experience in the pharmaceutical industry (at least 8yrs or more in parenteral DP packaging) may substitute.
Demonstrated technical leadership through successful interactions with senior business leadership and senior technical leaders
Significant experience in pharmaceutical packaging for parenteral drug products (syringes, vials, or cartridges)
Strong working knowledge of pharmaceutical industry regulatory directives, guidances, and compendial standards for packaging components and container closure systems
Strong technical problem-solving skills, strategic thinking, and demonstrated ability to identify problems and drive issue resolution / improvements.
Experience working in a diverse networked technical organization with proven skills to manage suppliers and alliance partners
Demonstrated ability to influence & coach/mentor others
Broad integrated technical knowledge for system and design engineering, product development, and commercialization (packaging, device, etc.) to enable success in DDCS Tech Lead role
- Limited Travel may be required to Lilly sites globally.
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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at email@example.com.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!