Sr. Principal Scientist - TS/MS Device & Packaging at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Medical Devices, HealthcareIndustries

Requirements

Strong ownership and stewardship for medical device design, manufacturing, labelling, and/or packaging processes
Ability to liaise with regulatory function to align on strategies for new products, packaging, platform changes, and consolidated technical change agendas
Understanding of key regulations (e.g., cGMP, ISO 14971, ISO 11608, OSHA) and their impact on medical device design transfer and post-launch surveillance
Engagement with external sources to stay current on risk management, state-of-the-art technology, regulatory, and compliance environments
Proficiency in preparing, reviewing, and approving study designs, protocols, technical reports, and technical documentation
Expertise in overseeing qualification and validation strategy for device and packaging processes
Ability to independently identify key engineering questions/issues and develop solutions to advance business objectives
Proficient data analysis and first principles applications for production issue resolution, investigation, reliable solutions, safe execution, and regulatory compliance
Experience supporting complex investigations, CAPA plans, and technology transfer agenda
Knowledge of lean tools, materials, process, automation, and product to improve robustness, reduce variability, and enhance control strategies
Capability to perform process monitoring of critical parameters

Responsibilities

Provide technical oversight as a Technical Subject Matter Expert (SME) for new and existing medicines on production lines, technical transfer, and optimization of control and capacity
Demonstrate flexibility, proactivity, and involvement in supported processes
Liaise with regulatory function and engage externally to improve strategies for design transfer and manufacturing processes
Prepare, review, and approve study designs, protocols, technical reports, and oversee qualification/validation strategies
Provide technical and effective process support for production issue resolution and investigations
Identify and drive improvement opportunities, implement technology transfer agenda, and ensure integration of Site business and Quality Systems
Support complex investigations of key issues/events and implement CAPA plans to prevent recurrence
Ensure adherence to regulatory requirements (cGMP, ISO 14971, ISO 11608, OSHA, environmental sustainability)
Support site inspection readiness, execution, and direct interaction with Regulatory Agencies
Identify weaknesses in control strategy and pursue improvements/resolution
Establish guidance and standards for operational and equipment control strategy
Develop local processes and procedures using lean tools to enhance efficiency
Use first principles and theoretical knowledge to define scientific approaches for technical expectations and process optimization

Skills

Medical Device Design

Manufacturing Processes

Packaging

Labeling

Technical Transfer

Regulatory Compliance

Risk Management

Post-Launch Surveillance

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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