Associate - Technical Operations - US Commercial at Eli Lilly and Company

Philadelphia, Pennsylvania, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, RadiopharmaceuticalsIndustries

Requirements

Bachelor’s degree in a scientific or technical area
Willing and able to travel within the US 30% of the time with potential for OUS travel

Responsibilities

Assist/Lead investigations into defects and failures in the field at US Commercial Manufacturing Sites
Troubleshoot Quality Control (QC) test method and production issues with CMO sites for the assigned region. Coordinate with the Radiochemistry & Radiopharmaceutical Development and Analytical Development and Quality Control teams as necessary
Identify and track root causes for production failures and support programs/solutions to improve site production performance
Conduct site visits to assigned CMO sites to troubleshoot issues and/or to observe production and testing of Avid products and review for compliance with Avid approved procedures and PET GMP regulations
Assist with supplemental training of CMO site staff during site visits to correct deficiencies
Assist with roll out of revised major QC test procedures or production processes to CMO
Lead data analysis projects for batch data for global CMOs for all products
Create technical summaries and trending reports based off all incoming batch data
Support projects related to management of incoming batch data for global CMOs for all products
Review and assess all changes to technical documents and for process improvement discussions with the CMOs
Author technical documents including but not limited to testing protocols, technical reports, and SOPs
Review completed manufacturing batch documentation
Support technology transfer and new site start-up as needed

Skills

Key technologies and capabilities for this role

TroubleshootingQuality ControlRoot Cause AnalysisGMP ComplianceRadiochemistryAnalytical DevelopmentInvestigationsCMO CoordinationSite VisitsPET GMP

Questions & Answers

Common questions about this position

What are the basic qualifications for the Technical Operations Associate role?

A Bachelor’s degree in a scientific or technical area is required.

What preferred skills or experience are mentioned for this position?

An advanced degree in a scientific or technical area is preferred, along with experience working with Radiopharmaceuticals and knowledge of cGMP drug substance.

Is this a remote position or does it require travel?

The role involves conducting site visits to assigned CMO sites to troubleshoot issues, observe production, and provide training, indicating travel is required.

What does the company culture emphasize at Eli Lilly and Avid Radiopharmaceuticals?

The company unites caring with discovery to make life better for people, puts people first, and focuses on discovering life-changing medicines while giving back through philanthropy and volunteerism.

What experience would make me a strong candidate for this role?

Candidates with an advanced degree, experience in radiopharmaceuticals, knowledge of cGMP, and skills in troubleshooting production issues or conducting investigations at manufacturing sites would stand out.

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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