Eli Lilly and Company · 2 weeks ago
Sr. Principal Scientist - TS/MS Device & Packaging
Indianapolis, IN
Full-time
Onsite
Senior Level, Lead/Staff
$114K/yr - $198K/yr
5+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving lives through innovative medicines. The Sr. Principal Scientist in the Device and Packaging Manufacturing division will provide technical oversight, support regulatory compliance, and drive process optimization to ensure the reliable supply of life-saving medications.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
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
Qualification
Required
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
Preferred
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%
Benefits
Company bonus
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2026-01-13
GlobeNewswire
2026-01-13
Company data provided by crunchbase