Sr Principal Scientist/Advisor - TSMS Packaging

Lilly • Indianapolis, IN

6d • $67,500 - $173,800

About The Position

The Sr. Principal Scientist/Advisor is a global technical role within Lilly’s Global Packaging and Robotics organization, supporting the technical oversight of commercial pharmaceutical packaging operations to help maintain reliable supply. The role works cross-functionally with packaging sites, external manufacturing sites, global functions, and other manufacturing and quality subject-matter experts and leaders. It supports new medicine introductions, technical transfers, new packaging sites and lines, new formats and presentations, and technical improvement agendas across the packaging network.

The position develops and implements harmonized packaging control strategies and standards covering packaging equipment and materials, device assembly, inspection, material movement, validation, qualification, process monitoring, stability, and shipping. It applies integrated risk management to packaging materials, equipment interfaces, warehousing, materials movement, and distribution. The role also supports governance and change management, regulatory strategy alignment, issue investigation and corrective and preventive action, and adoption of appropriate controls for new products.

The successful candidate provides on-site subject-matter expertise, coaching, and mentoring as needed for new line and platform installations, qualification of new formats, product technology transfer and validation, inspection readiness, implementation of technical agendas, and management of significant issues. The role stays informed about developing packaging technologies and industry practices, using relevant knowledge and benchmarks to identify opportunities for improvement. The role is open to U.S. and overseas candidates, with a preference for being located at or near a packaging site; travel is estimated at 10–25%.

Requirements

• Degree in Packaging, Mechanical, or Chemical Engineering, or another related engineering, scientific, or technical discipline, such as Materials Science, Pharmacy, or Chemistry.
• At least 5 years of experience in the pharmaceutical industry, ideally with experience supporting packaging.
• Availability to travel; estimated travel is 10–25%.
• Familiarity with and sensitivity to other cultures to interact effectively with colleagues in other parts of the world.

Nice To Haves

• Experience in both device and parenteral product development or manufacturing.
• Experience working at or in support of a manufacturing facility.
• Experience supporting pharmaceutical manufacturing, including commercialization and technology transfers of new products or processes, reliable supply, and problem solving.
• Understanding of quality systems and business processes such as validation, risk management, and control strategies.
• Excellent communication skills and ability to influence organizational and operational strategy without direct control.

Responsibilities

• Support existing and new packaging sites, including external manufacturing sites, with technical and knowledge transfer of control-strategy elements for new lines, product introductions, new formats and presentations, and technical changes.
• Implement integrated risk management covering packaging materials and equipment interfaces, warehousing and materials movements, and distribution.
• Establish guidance and standards for operational and equipment control strategies supporting packaging platforms, including material verification, standardization, PPM inspection, and supplier certification.
• Develop and implement integrated device assembly, packaging, PPM, and material-movement control strategies to reduce risks to reliable supply.
• Develop and implement harmonized network approaches and standards for performance qualification, process validation, ongoing process verification and monitoring, stability requirements, and qualification of shipping and material movements.
• Work with site personnel and global functions to promote platform approaches, replication, harmonization, best practices, and shared learning; participate in relevant network meetings.
• Support definition of a tier approach and governance model to sustain standards and harmonized approaches, and help establish change-management governance based on control-strategy tiers and defined roles and responsibilities.
• Liaise with regulatory functions to align regulatory strategies for new products, packaging, platform changes, and consolidated technical change agendas.
• Work with packaging and device development and global functions to influence the adoption of appropriate controls and methodologies for new products.
• Support packaging sites in investigating significant network-relevant issues and events and in identifying and implementing CAPA plans to address them and prevent recurrence.
• Travel to packaging sites as needed to provide subject-matter expertise, coaching, and mentoring for line and platform installation, format qualification, product technology transfer and validation, inspection readiness, technical agenda implementation, and issue management.
• Keep current with packaging technologies and new pharmaceutical platforms, including through industry forums, and use relevant benchmarks and learnings to assess improvements and strengthen reliable controls.

Benefits

• Company bonus, depending in part on company and individual performance.
• Company-sponsored 401(k) participation eligibility.
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefits eligibility.
• Flexible benefits, including healthcare and/or dependent day-care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior