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

Key technologies and capabilities for this role

Medical Device DesignManufacturing ProcessesPackagingLabelingTechnical TransferRegulatory ComplianceRisk ManagementPost-Launch Surveillance

Questions & Answers

Common questions about this position

What is the salary for this Sr. Principal Scientist position?

This information is not specified in the job description.

Is this role remote or does it require working at a specific location?

This information is not specified in the job description.

What key skills are required for this TS/MS Specialist role?

The role requires expertise as a Technical Subject Matter Expert in medical device design, manufacturing, labelling, and packaging processes, strong regulatory knowledge, proficient data analysis, and skills in innovation, problem-solving, and process optimization.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people, puts people first, and values giving best effort to work while contributing to communities through philanthropy and volunteerism.

What makes a strong candidate for this position?

Strong candidates demonstrate strong ownership and stewardship for medical device and packaging processes, are flexible, proactive, and involved, with expertise in regulatory compliance, innovation, problem-solving, and technical oversight.

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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