Lead Operator - Peptide Synthesis at Eli Lilly and Company

Lebanon, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

High School Diploma or equivalent
Legally authorized to be employed in the United States

Responsibilities

Maintain compliance with all regulatory requirements at all times
Support the execution of the production plan for the site
Carry out daily monitoring, testing, and cleaning duties as assigned on systems to ensure equipment and systems are in good operating conditions and maintained in accordance with local and corporate regulatory requirements
Enter Trackwise events, participate in and lead CAPA investigations
Troubleshoot and diagnose process problems and take appropriate actions to minimize deviations or site impact
Understand Health, Safety & Environmental-regulated environment and application of Health & Safety/Process Safety standards in order to execute key/critical GMP duties
Understand other area processes & their operational hazards and being able to react appropriately
Monitor and collect data on equipment use and performance (i.e., trying to anticipate potential equipment reliability problems)
Work with Maintenance and Technical Support to respond appropriately to potential utility supply upsets or equipment failure
Contact the appropriate help if there is a problem or an event (spill/deviation/incident) during processing
Communicate to other shifts regarding the status of the area operations and details of any issues/problems that have occurred at handover
Actively participate in assigned building & area operations such as safety audits, procedure co-ordination, housekeeping, and improvement projects
Be trained and qualified on all specified unit operations within the building
Identify concerns for informal or formal discussion (shift meetings, safety representative)
Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification

Skills

Key technologies and capabilities for this role

Peptide SynthesisAPI ManufacturingGMP OperationsUnit OperationsSafety ProtocolsQuality ControlChemical ProcessingManufacturing ProcessesProcess Startup

Questions & Answers

Common questions about this position

What is the employment type for this Lead Operator position?

The position is full-time employment.

Where is this job located?

The role is based at Lilly's advanced manufacturing facility in Lebanon, IN.

What key skills are needed for the Lead Operator role?

Key skills include maintaining regulatory compliance, troubleshooting process problems, understanding health, safety, and environmental standards, monitoring equipment performance, and participating in CAPA investigations.

What is the company culture like at this new manufacturing site?

The culture emphasizes a safety-first, quality-always mindset, significant collaboration, creativity, and resilience as the site grows into full-scale GMP manufacturing.

What makes a strong candidate for this Lead Operator position?

Strong candidates thrive in dynamic startup environments, bring experience in GMP operations, regulatory compliance, process troubleshooting, and are eager to help build processes and culture for a new greenfield site.

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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