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

Key technologies and capabilities for this role

cGMPmanufacturingshift leadershipproduction coordinationquality controlquality assuranceplant maintenancedrug productsradioisotopes

Questions & Answers

Common questions about this position

What is the work schedule for the Operations Supervisor role?

This is a direct line supervision of operators on a 12-hour shift.

What are the main responsibilities of the Operations Supervisor?

The role involves shift leadership of manufacturing employees, leading production of drug products following cGMP guidelines, resolving production and quality issues, coordinating with QC/QA and maintenance, ensuring staffing with trained employees, and adhering to safety with radioactive materials.

What skills or expertise are required for this position?

Candidates need to be subject matter experts in manufacturing to resolve issues, experienced in manual/automated aseptic radiopharmaceutical production per batch records, skilled in leading investigations of deviations and OOS events, and knowledgeable in monitoring production equipment and safety with radioactive materials per ALARA and NRC guidelines.

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 who contribute to communities through philanthropy and volunteerism.

What makes a strong candidate for the Operations Supervisor position?

Strong candidates are subject matter experts in manufacturing who can lead shifts, resolve production issues timely, ensure cGMP compliance, coordinate cross-functionally, staff trained teams, and maintain safety with radioactive materials.

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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