Lead Operator - Manufacturing at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, BiotechnologyIndustries

Requirements

Experience in aseptic production of radiopharmaceutical drug product and radioisotopes
Knowledge of cGMP guidelines and compliance requirements
Ability to safely work with radioactive materials following ALARA principles and NRC guidelines
Familiarity with manufacturing batch records and SOPs
Capability to monitor and utilize manufacturing-related equipment, ensuring performance, safety, calibration, and PM schedules
Skills in investigating, resolving, and mitigating deviations, non-conformances, and OOS events
Experience supporting technical transfer, development, and validation of production methods

Responsibilities

Produce drug products following cGMP guidelines and resolve production-related quality events in a timely manner
Support daily production and inspection activities
Contribute to process improvements and continuous improvement of manufacturing methods
Serve as backup to the Team Leader to ensure operational continuity
Coordinate production activities with Quality Control, Quality Assurance, FUME, and Engineering for on-time release of drug products and radioisotopes
Participate in technical transfer and process validation activities
Conduct and document aseptic production of radiopharmaceutical drug product and radioisotopes
Safely handle and transfer radioactive materials throughout the facility
Monitor production-related equipment for proper function, performance, and safety standards

Skills

Key technologies and capabilities for this role

Manufacturing ProcessesRadiopharmaceuticalsProcess SupervisionOncology ProductionGMP

Questions & Answers

Common questions about this position

What is the salary or compensation for the Lead Operator position?

This information is not specified in the job description.

Is this Lead Operator role remote or onsite?

This information is not specified in the job description.

What key skills are required for the Manufacturing Process Specialist role?

The role requires skills in aseptic production of radiopharmaceuticals, technical transfer and validation of production methods, investigating deviations and OOS events, monitoring production equipment, and continuous process improvement under cGMP.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people, puts people first, gives best effort to work, and seeks determined individuals; they emphasize philanthropy, volunteerism, and transforming precision oncology.

What makes a strong candidate for this Lead Operator role?

Strong candidates have experience in aseptic manufacturing, cGMP compliance, process validation, deviation investigation, equipment monitoring, and can serve as backup Team Leader while supporting production improvements in radiopharmaceuticals.

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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