Isotope Manufacturing Scientist
Listed on 2026-07-08
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Manufacturing / Production
Pharmaceutical Manufacturing, Production QC/QA, Chemical Manufacturing, Quality Engineering
The Isotope Manufacturing Scientist will support the development, scale-up, and implementation of isotope manufacturing technologies at Perspective's new radiopharmaceutical manufacturing facility. This role combines applied scientific expertise with hands‑on operational execution, ensuring that isotope processing activities are translated into reliable daily operations aligned with the facility's technical and regulatory requirements.
Working closely with cross‑functional partners, the Scientist serves as a key contributor in bridging process development and translation to routine manufacturing execution. A central responsibility is applying technical judgment to execute and refine isotope processing workflows, hot cell operations, and analytical testing, while supporting the transition of laboratory‑scale processes into a cGMP‑compliant manufacturing environment.
The role requires a technically strong scientist who leads hands‑on process development and implementation and analytical work, troubleshoots processes based on data interpretation, and ensures safe, compliant, and consistent operations. The Scientist supports documentation, training, and continuous improvement efforts, contributing to a strong safety and quality culture while collaborating with Quality, Operations, Facilities, and Safety teams to meet operational priorities.
Essential Functions- Lead and execute hands‑on isotope production process development, including radioisotope separations within a hot cell environment
- Facilitate the transfer and scaling of R&D processes into standardized routine operations
- Conduct operations within hot cells using remote manipulators
- Handle alpha, beta, and gamma‑emitting materials in accordance with radiation safety requirements and ALARA principles
- Support the development of procedures, experimental protocols, development reports, batch records, and documents supporting regulatory submissions
- Perform basic equipment troubleshooting and support preventive and corrective maintenance
- Perform analytical testing (e.g., gamma spectroscopy, alpha spectroscopy, dose calibration) to evaluate isotope product activity, purity, yield, and process performance
- Perform chemical laboratory operations including safe acid handling, precise weighing and solution preparation, and general laboratory safety practices
- Train, mentor, and support production staff on radio chemical processes, hot cell operations, GMP expectations, and safety protocols
- Serve as a technical resource for isotope manufacturing and radiopharmaceutical processing, providing execution‑level support for continuous improvement initiatives
- Support facility planning and equipment integration for radioisotope development and production by providing hands‑on operational input and testing support
- Contribute to isotope scale‑up initiatives, QA/QC processes, and supply chain coordination through execution, troubleshooting, and data generation
- Bachelor’s, Master’s, or PhD degree in Chemistry, Chemical Engineering, Radiochemistry, or related field.
- 3‑5+ years of experience in radiochemistry, radiopharmaceutical, isotope manufacturing, or cGMP manufacturing environments
- Hands‑on experience working in hot cells, shielded environments, or with radioactive materials
- Strong skills to perform chemical operations in a hot cell environment using remote manipulations
- Deep understanding of radio chemical processes, metrology, and separation chemistry.
- In depth knowledge of safety requirements, including radiation safety, ALARA principles, contamination control, chemical compatibility, and hazardous material handling
- Excellent communication skills, the ability to clearly document executional observations and processes.
- Ability to perform precise laboratory techniques such as solution preparation and manipulation of materials in controlled and shielded environments
- Demonstrated ability to execute and refine defined processes for scaled manufacturing.
- Familiarity with cGMP, FDA, NRC, and other applicable regulatory frameworks.
- Comfortable working in a fast‑paced, cross‑disciplinary environment.
- Ability to work in a rapidly changing…
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