Director– Sterility Assurance at Eli Lilly and Company

Indianapolis, Indiana, United States

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$147,000 – $242,000Compensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Strong understanding of Sterility Assurance principles and practices
Experience in driving and implementing technical programs
Ability to influence and collaborate with cross-functional teams
Excellent communication and presentation skills
Demonstrated leadership abilities

Responsibilities

Assess differences in current sterility assurance programs across sites and drive harmonization
Work closely with site and multi-functional SMEs to drive cohesion and ensure control strategies are robust and consistent with regulatory and compliance expectations
Assume SME leadership role for a specific topic area within Sterility Assurance across the network
Represent TS/MS on network Science Lead Team and other governance forums
Ensure that Sterility Assurance programs are frequently presented to network team to align across sites
Ensure that learnings and best practices are shared across sites – set up appropriate forums and present case studies to site SMEs
Provide mentoring leadership to site SMEs to build technical capability
Provide ad-hoc technical support to Lilly R&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing

Skills

Sterility Assurance

Technical Programs

Regulatory Compliance

Cross-functional Collaboration

Leadership

Communication

Presentation Skills

Quality Assurance

SME Leadership

Harmonization

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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