Sr. Operator, Production Technician 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, Biotechnology, HealthcareIndustries

Requirements

Ability to safely work with radioactive materials following ALARA principles and NRC guidelines
Knowledge of cGMP, cGLP, and aseptic production techniques
Experience or ability to work in classified cleanroom environments, including maintaining aseptic technique and adhering to gowning procedures
Capability to perform manual, semi-automated, or automated visual inspection of finished pharmaceutical products (vials) to detect particulates, cosmetic defects, or container/closure integrity issues
Ability to apply defect classification criteria accurately and consistently in alignment with SOPs and regulatory standards
Strong collaboration skills to work with Quality Control, Quality Assurance, Plant Maintenance, maintenance technicians, equipment manufacturers, and other departments
Ability to work well in a fast-paced team environment
Clear and concise verbal and written communication skills for providing reports to supervisors
Attention to detail for maintaining accurate and complete lab data notebooks

Responsibilities

Produce radioisotopes and drug products following cGMP guidelines and resolve all production-related quality events in a timely manner
Coordinate production activities with Quality Control, Quality Assurance, and Plant Maintenance to facilitate on-time release of drug product and radioisotopes
Participate in technical transfer and process validation activities in collaboration with other departments
Safely handle and participate in the transfer of radioactive materials throughout the facility
Utilize and monitor all manufacturing-related equipment to ensure performance and safety standards are met
Collaborate with maintenance technicians, equipment manufacturers, and quality assurance to ensure that all production equipment is in good working order and is validated for use
Conduct and appropriately document aseptic production of radiopharmaceutical drug product and radioisotopes via strict adherence to manufacturing batch records and affiliated SOPs
Monitor production-related equipment to ensure proper function and compliance with the established calibration/PM equipment schedule
Investigate, resolve, and mitigate deviations, non-conformances, and OOS (Out of Specification) events associated with product manufacturing
Support the technical transfer, development, and validation of production methods associated with finished dosage form (FDF) drug products and radioisotope products
Continuous process improvement of existing manufacturing methods via cGMP
Maintain accurate and complete lab data notebooks as per cGLP and/or cGMP
Adhere to all applicable procedures, cGLP, cGMPs, company policies, and any other quality or regulatory requirements
Embody and promote a quality culture and due diligence approach as part of all activities
Perform other duties as assigned

Skills

cGMP

Aseptic Production

Radiopharmaceutical Manufacturing

Batch Records

Technical Transfer

Process Validation

Deviation Investigation

OOS Investigation

Equipment Calibration

Preventive Maintenance

Continuous Improvement

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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