Scientist / Principal Scientist – TSMS PAR 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

PharmaceuticalsIndustries

Requirements

Bachelor's degree or higher in engineering, packaging science, or related field
2+ years experience in cGMP manufacturing preferred (validation, engineering, TSMS, operations, QA, etc.)
Pharmaceutical and/or medical device manufacturing experience
Root Cause Investigation Experience
Proficiency with computer systems including Microsoft Office products, Veeva Vault, TrackWise/MasterControl, electronic systems

Responsibilities

Support the assigned Process Team (formulation, filling, or VI) as TSMS representative
Serve as floor-level support and technical interface for manufacturing components, equipment, and operations for the TSMS team
Represent Lilly Kenosha County TSMS team for internal and external communications on a regular basis
Lead risk management activities as it pertains to product/process
Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues
Prepare and Review or approve, as required, relevant technical documents such as: Annual Product Reviews, Change Controls, Regulatory Submissions, Deviations, Validations, Procedures, PFDs, PFMEAs, etc
Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability
Identify opportunities and lead technical projects to improve process control and/or productivity
Serve as interface with upstream suppliers and parenteral product networks
Drive stability strategy for Lilly Kenosha County products
Provide Audit support as needed
Author and execute protocols as well as conduct root cause investigations
Maintain the validated state of applicable processes, establish and monitor metrics/methods to ensure a state of capability and control, harmonization of control strategies across process teams, evaluate process improvement, and serve as an escalation point for day-to-day operations issues (upon start of commercial production)

Skills

Process Validation

Technical Transfer

Root Cause Investigation

Formulation

Filling Operations

Visual Inspection

Protocol Execution

Process Monitoring

Control Strategies

Process Improvement

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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