Associate Director TSMS Sterility Assurance at Eli Lilly and Company

Alzey, Rhineland-Palatinate, Germany

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceutical, HealthcareIndustries

Requirements

Develops and maintains up-to-date technical/scientific knowledge and expertise in sterility assurance (QA/QC, microbiology, environmental monitoring, TS/MS, engineering, sterile manufacturing, etc.)

Responsibilities

Responsible for technical investigations or evaluations, and sterility assurance improvement projects
Evaluates, suggests, and makes decisions on technical solutions during project activities or change controls, including approving or rejecting them
Defines, develops, evaluates, and validates on-site sterility assurance strategies to ensure compliance with current regulations and Lilly Global Quality Policies and Common Quality Practices
Reports sterility assurance quality issues and inspection risks to site leadership as part of site reviews and in global forums as appropriate
Actively participates in regulatory inspections, internal audits, or global audits as a key contact for sterility assurance
Serves as a primary contact for all matters related to sterility assurance during Health Authority inspections, internal audits and as needed

Skills

Sterility Assurance

QA/QC

Microbiology

Environmental Monitoring

Sterile Manufacturing

Technical Investigations

Regulatory Compliance

Audits

Validation

Quality Assurance

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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