Production Operator
Lillyabout 1 year ago
Indianapolis, Indiana, United States
On-site
Full-time
Junior Level (1-3 years)
Job Description
Position Overview
At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, Lilly and its wholly owned subsidiary, POINT Biopharma Global Inc., are dedicated to transforming precision oncology through radiopharmaceutical innovations. POINT focuses on the clinical development and commercialization of targeted radioligand assets, combining a seasoned management team, a strong pipeline, in-house manufacturing capabilities, and secured supply of key medical isotopes. This role is integral to ensuring the aseptic production and quality assurance of radiopharmaceutical drug products and radioisotopes in a state-of-the-art GMP facility.
Key Responsibilities
- Aseptically produce radiopharmaceutical drug products and radioisotopes in accordance with manufacturing batch records and SOPs.
- Support technical transfer, development, and validation of production methods for finished dosage forms and radioisotope products.
- Investigate, resolve, and mitigate deviations, non-conformances, and Out-of-Specification (OOS) events at the GMP facility.
- Monitor and maintain production equipment per calibration and preventive maintenance schedules.
- Drive continuous process improvement of manufacturing methods in compliance with cGMP and cGLP guidelines.
- Coordinate production activities with Quality Control, Quality Assurance, and Plant Maintenance to ensure timely release of products.
- Follow ALARA principles and NRC guidelines while safely handling radioactive materials.
- Document production activities and maintain accurate lab data notebooks.
- Communicate clearly with supervisors and cross-functional teams regarding production and quality events.
Required Qualifications
- High School diploma, certificate, or a 2-year associate's degree in a science-related field.
- 2 to 5 years of relevant experience in a manufacturing or similar environment.
Preferred Qualifications
- Experience in aseptic and/or cGMP manufacturing processes.
- Exposure to radiopharmaceutical production is an asset.
- Ability to maintain focus on complex tasks for prolonged periods.
- Strong verbal and written communication skills with a keen attention to detail.
- Team player with excellent organizational and interpersonal skills.
- Proficiency in Microsoft Office applications.
Benefits & Perks
- Compensation: Base salary ranging from $36,000 to $71,500, with an anticipated hourly wage of $17.30 - $34.38 and eligibility for a company bonus based on performance.
- Benefits: Comprehensive program that includes a company-sponsored 401(k), pension plan, and eligibility for medical, dental, vision, and prescription drug benefits.
- Additional perks include flexible spending accounts, life insurance, paid time off, and well-being benefits such as employee assistance programs and fitness benefits.
- Shift work is required with a 12-hour rotation schedule (either 7a-7p or 7p-7a) on a 3-2-2-3 basis.
Required Skills
cGMP Manufacturing
Deviation Investigation
Quality Assurance
Safety Compliance
Documentation
Process Validation
Technical Transfer
Equipment Calibration
Aseptic Production
Process Improvement