At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
Organization Overview:
For nearly 150 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.
As part of Global Packaging and Robotics, Global Packaging Process Engineering and Serialization is responsible for providing engineering and technical support for Lilly commercial packaging operations worldwide, that includes asset delivery and the management of the Global Serialization Program.
Position Brand Description:
The TSMS Sr. Principal Scientist/ Advisor for the Packaging network must be an experienced technical professional with 5+ years of experience in the manufacturing/technical support of human pharmaceutical packaging of Drug Products intended for direct use by healthcare professionals and patients.
This global TSMS role should provide technical oversight for reliable supply of commercial medicines and will work, cross functionally with sites and global functions, to assure the successful and harmonized approach for new medicines introduced on packaging lines, support technical transfer to and implementation of new packaging sites/lines, develop an agenda of technical improvements for packaged products, ensure standardized control strategies across the packaging sites, and optimize capacity to maintain reliable supply for current and future products across the device/pack network.
As a global functional, part of Global Packaging and Robotics organization, the Sr. Principal Scientist/Advisor will work closely with other M&Q functional SMEs and leaders across the network including DAP network, Parenteral and Dry Products network, IDM, DDCS and liaise closely with site functional SMEs and leaders throughout the pack network.
Key Objectives/Deliverables/Responsibilities
· Support the network of existing and new packaging sites including external manufacturing sites for technical transfer/knowledge transfer of control strategy elements for new packaging lines, new product introduction, implementation of new formats/presentations and the technical change agenda.
· Implement an integrated risk management approach that encompasses packaging materials and equipment (interfaces), warehousing/materials movements, and distribution.
· Establish guidance and standards for critical aspects of the operational and equipment control strategy supporting packaging platforms (including material verification, standardization, etc. Also control strategies of PPM inspection and supplier certification).
· Develop and implement holistic, integrated device assembly/packaging/PPM and material movement control strategies to minimize risks to reliable supply.
· Establish guidance and standards for critical aspects of the operational and equipment control strategy supporting packaging platforms.
· Develop and implement harmonized approaches, strategies and standards across the network of packaging sites in areas such as performance qualification, process validation, ongoing process verification/process monitoring, stability requirements and qualification of shipping/material movements.
· Work with packaging…