Sr Principal Scientist/Advisor - TSMS Packaging

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, 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.
• 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 TSMS site personnel and global functions to assure platform approach, ensure replication, harmonized approaches with the identification of best practices and continuous shared learnings.
• Provide support in defining a Tier approach and governance model to ensure application of standards/replication and assure harmonized approaches are sustainable and maintained over time.
• Participate in the establishment of an efficient change management governance process based on the control strategy tiers and defined roles and responsibilities.
• Liaise with regulatory function to align on regulatory strategies for new products, packaging, platform changes and planning for consolidated technical change agendas.
• Interface with packaging/device development and global functions to influence adoption of most appropriate controls/methodologies for new products.
• Support the network of packaging sites in the investigation of key network relevant issues and events and work with the site(s) in the identification and implementation of CAPA plans to address such events and prevent recurrence.
• Travel to packaging sites to provide on-the-ground subject matter expertise, coaching and mentoring of site personnel in support of the installation of new lines/platforms, qualification of new formats/presentations, new product tech transfer/validation, inspection readiness, technical agenda implementation, and key issues and events management.
• Stay current with developing technologies for packaging and new platforms in the pharma industry, participating in appropriate industry fora and using knowledge, benchmark and learnings gained to assess opportunities to implement improvements and enhance reliable controls at Lilly sites.

Basic Qualifications

• Degree in Packaging/Mechanical/Chemical Engineering or other related engineering/scientific/technical disciplines (e.g. Material Sciences, Pharmacy, Chemistry).
• A minimum of 5 years' experience in the pharmaceutical industry, ideally supporting packaging during this time.

Additional Skills/Preferences

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

Additional Information

• Familiarity with and sensitivity to other cultures will be very beneficial.
• Availability to travel, estimated to be in the range of 10-25%.
• This global TS/MS role, while posted with primary location as Indianapolis, is open to US and OUS candidates with a preference that the candidate is located at/in proximity to a site engaged in packaging activities.