Sr Principal Scientist/Advisor - TSMS Packaging

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 TSMS site personnel and global functions to assure platform approach, ensure replication, harmonized approaches with the identification of best practices and continuous shared learnings. Participate on network meetings of sites/relevant functions in this endeavor.
• Provide support in the work to define a Tier approach and the governance model to ensure the 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.
• Be prepared to travel to the 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 to assure successful transition to commercial manufacture and to ensure reliable supply.
• Stay current with developing technologies for packaging and new platforms in the pharma industry - for example participate in appropriate industry fora and use the 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 also 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.

Education Requirements:

Degree in Packaging/Mechanical/Chemical Engineering or other related engineering/ scientific/ technical discipline (e.g. Material Sciences, Pharmacy, Chemistry).

Additional Information:

Familiarity with and sensitivity to other cultures will be very beneficial in enabling this position to effectively and positively interact with colleagues in other parts of the world.

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.

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 a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

$67,500 - $173,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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