Sr. Principal Scientist, Quality Control - Laboratory Informatics at Eli Lilly and Company

Pleasant Prairie, Wisconsin, 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, BiotechnologyIndustries

Requirements

Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience
Minimum 6 years in the pharmaceutical industry with specific Quality Control and laboratory computer system experience
On-site presence required

Responsibilities

Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals
Performs or supports the laboratory with the validation of laboratory equipment and software systems
Supports the establishment and maintenance of the validated state of software-based computerized systems in use in the lab
Ensures data integrity by design within the QC laboratory
Leads site deployment and upgrade of QC laboratory IT systems such as Empower, NuGenesis, MODA, and Labvantage
Partners and builds relationships with Global Quality Laboratory Network and Global IT team members
Acts as business owner and subject matter expert for QC laboratory IT systems
Collects data and authors management review documents for the laboratory quality system
Provides oversight and supports continuous improvement of quality systems as they relate to the QC lab
Applies knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices
Assists in improvement of quality systems by creating or revising worksheets, developing or updating laboratory execution system documentation, updating laboratory methods, and maintaining other lab documentation systems
Manages and supports audit and inspection activities for the laboratory
Manages methods in the QC Laboratory
Performs and mentors others in change control, analytical investigations, root cause investigations, and activity planning
Implements and complies with corporate, site, and laboratory safety standards
Develops training materials

Skills

Laboratory Informatics

Quality Control

IT Systems

Regulatory Audits

Quality System

Laboratory Metrics

Safety Initiatives

Mentoring

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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