Operations Supervisor (Indy RLT) at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Subject matter expertise in manufacturing to resolve production-related and quality events
Knowledge of cGMP guidelines, ALARA principles, and NRC guidelines for working with radioactive materials
Ability to lead shift operations on a 12-hour shift with direct supervision of operators
Capability to coordinate with Quality Control, Quality Assurance, and Plant Maintenance
Experience in aseptic radiopharmaceutical drug product and radioisotope production (manual/automated)
Skills in technical transfer, development, and validation of production methods
Adherence to health, safety, radiation safety guidelines, policies, and SOPs

Responsibilities

Lead shift manufacturing employees and production of drug products following cGMP guidelines
Resolve or escalate manufacturing issues, deviations, non-conformances, and OOS events
Coordinate production activities with QC, QA, and Plant Maintenance for on-time release
Ensure manufacturing lines are staffed with trained/qualified employees
Monitor production equipment function and report maintenance needs
Organize and schedule manufacturing activities, technicians, and specialists per production plan
Lead investigations for quality events and implement CAPA with effectiveness checks
Track and trend batch data to meet manufacturing and quality KPIs
Ensure staff adherence to safety, radiation safety, and cGMPs
Provide training and guidance to production staff
Serve in direct production role as needed
Aid in qualifying equipment and clean rooms
Participate in Process Team activities and lead continuous process improvement initiatives

Skills

cGMP

manufacturing

shift leadership

production coordination

quality control

quality assurance

plant maintenance

drug products

radioisotopes

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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