Sr. Principal/Advisor – Sterility Assurance at Eli Lilly and Company

Indianapolis, Indiana, United States

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$114,000 – $198,000Compensation

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

Full TimeJob Type

UnknownVisa

PharmaceuticalIndustries

Requirements

(Not explicitly specified in the job description)

Responsibilities

Provide oversight and drive/maintain harmonization of technical programs governing Sterility Assurance control strategies across the Lilly Parenteral Product Network (PPN)
Influence peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies align with technical, quality, and regulatory guidance
Aid in building technical capability at Lilly sites
Provide ad-hoc technical support to Lilly PR&D, QC Microbiology, external contract manufacturing, and non-sterile drug substance (API) manufacturing
Support global quality standard development, sterility assurance work streams, new filling line startup, KPI development, and new regulation assessment
Assess differences in current sterility assurance programs across the sites and drive harmonization
Work closely with site and cross-functional SMEs to drive alignment
Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved
Support TS/MS SA on network and other appropriate governance forums
Ensure that Sterility Assurance programs and alignment topics are frequently presented to network team in order to achieve alignment across sites
Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs
Provide mentoring leadership to site SMEs to help build capability, particularly at the newer sites or where deep technical expertise is needed
Provide technical support to new sites / filling lines during design and start-up activities to ensure sterility assurance programs and process / product requirements are supported
Assist in building technical capability in sterility assurance at a site level to enable sustained compliance during commercial activities

Skills

Sterility Assurance

Microbiology

Regulatory Compliance

Quality Assurance

Pharmaceutical Manufacturing

Parenteral Products

GMP

KPI Development

Risk Assessment

Technical Governance

Filling Line Startup

Cross-functional Collaboration

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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