Radiopharmaceutical Production Technologist II (1st Shift)
About The Position
The Radiopharmaceutical Production Technologist II is responsible for producing radiopharmaceutical products in a just-in-time, GMP-regulated environment to support clinical and commercial supply. This role ensures safe handling of radioactive materials, strict adherence to aseptic techniques, and reliable execution of manufacturing processes. Technologist II participates in daily production, equipment and cleanroom readiness, isolator operations, batch record execution, and deviation support. This position is based in New Jersey and requires a presence on-site, and open to applicants authorized to work for any employer within the United States.
Requirements
- Bachelor’s degree in a scientific discipline with 1–3 years of GMP cleanroom manufacturing experience OR 5–7 years of equivalent experience
- Willingness to work with radioactive materials.
- Ability to work in controlled manufacturing environments with PPE.
- Understanding of GMP/GLP principles.
- Knowledge of hazardous material safety and cGMP requirements.
- Strong attention to detail and documentation accuracy
- Handling of and, or exposure to potentially hazardous chemical, radiological and or biological materials. Required to follow all safety procedures and use personal and protective equipment provided.
Nice To Haves
- Aseptic fill-finish experience, including familiarity with aseptic manufacturing technologies and facilities is preferred.
- Experience with radiopharmaceuticals (I-131, Lu-177, etc. or PET F-18, Cu-64) preferred.
- Previous lab experience in Manufacturing and/or Quality Control at aseptic processing facility is preferred.
- Previous experience in Quality, Compliance and/or Manufacturing of radiopharmaceutical products is preferred.
Responsibilities
- Execute and verify daily radiopharmaceutical production activities according to approved batch records and SOPs.
- Support production readiness including manual cleaning of cleanrooms, environmental monitoring, and isolator sterilization.
- Perform manufacturing operations using automated and manual synthesis systems.
- Conduct aseptic dispensing of individual product vials within isolator cells
- Prepare and stage materials while maintaining traceability.
- Maintain and prepare production equipment and cleanrooms
- Assist in deviation investigations and inspections
- Participate in qualification and validation activities.
- Follow all radiation safety and PPE requirements.
- Support Investigation Review Board and Change Control Review Board meetings as required.
- Remain current and apply knowledge of FDA CFR 210/211 and other regulatory standards and guidance in the pharmaceutical industry.
Benefits
- Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award.
- Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage.
- Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits.
- In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
