Associate Director-Test-Methods/Systems-IDM 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, Healthcare, Medical DevicesIndustries

Requirements

Strong leadership and supervisory experience
Ability to work across boundaries (with equipment suppliers, Lilly Mfg. sites, parts suppliers, development teams, etc.)
Mechanical aptitude (ideally knowledge of mechanical equipment, controls, and validation for medical devices)
Knowledge of manufacturing (ideally discreet manufacturing)
Understanding of GMP and ISO requirements relative to drug delivery devices
Understanding analytical test system and test method requirements for drug delivery devices
BS or MS in engineering, preferably mechanical engineering

Responsibilities

Develop, recruit and retain technical personnel to support the current and anticipated analytical methods and metrology for the portfolio of current and future delivery devices and primary containers that are integrated with devices
Develop and maintain the standards by which device analytical methods and test systems are developed, validated, and transferred to sites
Develop and maintain the qualified state of test systems used in support of device and cartridge analytical methods
Provide method and analytical test system oversight for the registered lot release methods as well as in-process testing of devices, containers and components
Provide business needs through the business planning process (long-range and yearly plans)
Execute all tasks while meeting Safety and Quality objectives of the organization
Communicate status and manage change for all activities via regular updates to the management teams (development and manufacturing), CMC project management, and manufacturing sites leadership groups
Provide customer service for manufacturing sites of primary container, drug delivery devices, and their components for testing needs such as investigations, continuous improvement activities, technical support, etc
Participate and lead in governance processes – change management boards, and quality lead teams
Lead laboratory priorities for TS/MS by providing direction and resourcing for engineering studies, design of experiments, etc
Human Resources Management for all direct reports

Skills

Key technologies and capabilities for this role

analytical methodsmetrologytest systemsmethod validationmethod transferpersonnel developmentbusiness planningchange managementCMC project managementcontinuous improvement

Questions & Answers

Common questions about this position

What are the minimum requirements for this role?

The position requires strong leadership and supervisory experience, ability to work across boundaries with various teams and suppliers, mechanical aptitude with knowledge of mechanical equipment, controls, and validation for medical devices, knowledge of manufacturing ideally in discreet manufacturing, understanding of GMP and ISO requirements for drug delivery devices, and understanding of analytical test system and test method requirements for drug delivery devices.

What additional preferences are there for candidates?

Preferred qualifications include understanding of statistics and design of experiments, as well as experience in drug delivery systems and technologies such as pre-filled and re-usable devices.

Is this a remote position or does it require working in an office?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What does Eli Lilly's company culture emphasize?

Eli Lilly unites caring with discovery to make life better for people around the world, puts people first, and encourages giving back to communities through philanthropy and volunteerism.

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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