Lead Secondary Packaging Development Engineer at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, HealthcareIndustries

Requirements

Expertise in patient-centered packaging design and secondary packaging structures (carton, tray, printed materials, labels, adhesives)
Knowledge of product stability testing against shipping hazards (vibration, shock, vacuum, thermal stresses)
Ability to develop and qualify shipping containers and packing/shipping processes
Proficiency in engineering risk assessment (e.g., DFMEA, AFMEA)
Experience with control strategy elements (specifications, inspection/testing procedures)
Regulatory compliance knowledge (USP, EP, JP, CFR, ASTM, ISTA)
Ability to provide regulatory submission support and ensure compliant work products
Skills in documentation for tech transfer and regulatory submissions
Capability to mentor lower-level engineers and contingent workers
Experience driving technical agendas, process improvements, and incorporating innovations

Responsibilities

Partner with Device development, Business Unit, and Human Factors teams to drive patient-centered packaging design requirements
Design, develop, and qualify secondary packaging structures to enable clinical portfolio development and product launch
Define and verify product stability requirements against shipping hazards
Develop and qualify shipping containers and associated packing/shipping processes for clinical and commercial distribution
Develop suitability rationale for secondary packaging and shipping
Complete documentation to support tech transfer and regulatory submissions
Assess engineering risk for secondary packaging and shipping (e.g., DFMEA, AFMEA)
Define and establish control strategy elements such as specifications and inspection/testing procedures
Mentor lower-level engineers and contingent workers
Drive packaging-related technical engineering agenda items and process improvements
Incorporate technical advancements and innovations into the current portfolio
Provide regulatory submission support
Ensure work products comply with applicable standards (e.g., USP, EP, JP, CFR, ASTM, ISTA)
Ensure timely review/approval of methods, departures, procedures, protocols, and changes
Ensure appropriate safety practices and procedures are followed
Maintain close partnership with key development customers to integrate package development deliverables

Skills

Secondary Packaging

Packaging Development

Container Closure Systems

Medical Devices

Pharmaceutical Packaging

Qualification

Drug Product Development

Delivery Systems

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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