Sr. Principal Scientist - TS/MS Device & Packaging

• Demonstrate a strong ownership and stewardship for medical device design, manufacturing, labelling, and/or packaging processes you support by being flexible, proactive and involved.
• Liaise with regulatory function to align on strategies for new products, packaging, platform changes and planning for consolidated technical change agendas. Understand key regulations and their impact to the medical device design transfer and post-launch surveillance process.
• Engage externally to ensure the organization stays current in the evolving risk management, state-of-the-art technology, regulatory and compliance environment. Leverage these to improve strategies and applications for developing and controlling design transfer and manufacturing processes.

• Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. Oversee qualification and validation strategy for device and packaging processes.
• Independently identify the key engineering questions/issues and develops solutions to advance business objectives.

• Provide technical and effective process support services for production issue resolution and investigation with proficient data analysis and first principles applications, ensuring reliable solutions, safe execution, and regulatory compliance.

• Identify and drive improvement opportunities. Implement the organization’s technology transfer agenda, ensuring seamless integration and replication of Site business and Quality Systems for Commercial Launch/Technical Agenda activities.

• Support complex investigation of key issues and events and work on the identification and implementation of CAPA plans to address such events and prevent recurrence.

• Ensure adherence to current regulatory requirements, including cGMP standards, ISO 14971, ISO 11608, OSHA regulations, and environmental sustainability goals.
• Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections.
• Identify weaknesses and opportunities in control strategy and pursue improvements and resolution.
• Establish guidance and standards for critical aspects of the operational and equipment control strategy supporting device and packaging platforms.

• Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean tools for success.
• Use first principles and theoretical knowledge to define scientific approaches to support technical expectations. Utilize in depth understanding of materials, process, automation, and product to improve. product/process robustness, reduce variability, and provide improvement in control strategies.
• Perform process monitoring of critical parameters and react to signals/trends to drive continuous improvement, process capability and prevention of issues.

• Foster knowledge sharing and education within the team and with key internal and external partners to drive alignment, share best practices, technical principles and meet manufacturing goals.
• Collaboratively integrate different disciplines such as engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness.

• Mentor and provide coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors. This may include coaching on first principles, change or deviation management and processing issue resolution.
• Create a safe and encouraging environment for colleagues to share ideas, contribute and thrive.
• Willingness to openly share, to speak up and ensure others understand the risks when making business choices and decisions.

• Lead by example in building and driving a culture of safety first and quality always within the organization.
• Author, Review and/or approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.

• Bachelor’s degree in Science, Engineering, or related field.
• 5+ years of experience in pharmaceutical and/or medical device manufacturing or regulated industry.
• Strong understanding of cGMPs and pharmaceutical or regulated industry manufacturing.
• Ability to lead complex technical projects and make informed decisions.

• Prior experience in packaging and/or device assembling operations.
• Familiarity with Commercialization process and Process Control requirements.
• Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and types of audiences (internal and external) to influence and/or drive common understanding and appropriate actions.
• Ability to work well independently, as well as in teams. Provides partnership and collaboration across multiple disciplines.
• Demonstrated, strong analytical and problem-solving abilities.
• Project management experience and basic statistical skills.
• Working knowledge of equipment and facility qualification processes.
• Safety equipment (PPE) and precautions required in the manufacturing plant environment.
• Variable travel may be required to support business needs, 0-50%.

Eli Lilly