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Our Radiochemistry & Molecular Imaging Probes team is seeking a talented Clinical Radiochemist . The position requires the ability to successfully transition new and existing radiopharmaceutical agents from the preclinical setting to routine manufacturing for clinical use. Extensive focus on generation of GMP documentation, manufacturing process optimization and automation, and technician training. This position will work closely with other radiochemists and molecular imaging scientists, pharmacists, and the MSKCC Investigational Products Core to assure safe and reliable clinical production of radiopharmaceutical agents. Significant responsibility for the translational process coordination; generation, review, submission, and implementation of the Standard Operating Procedure's (SOP's), Chemistry Manufacturing and Controls (CMC) documentation, CMC amendment documentation; production technician training; and any other subject deemed appropriate by the Cyclotron Radiopharmacy Supervisor
Generation of legible, accurate, and detailed SOP's describing the final approved manufacturing process.
Review of the new and existing SOP'S and CMC sections to ensure that they accurately reflect the actual manufacturing process.
Perform utilization of the RMIPC Quality Assurance system.
Generate, review, and approval of the content in the final versions of the original CMC documentation and/or final versions of amendment documentation.
Manufacturing and QC equipment validation, operation, cleaning, and maintenance SOP generation and implementation.
Assure projects are completed within the timeframe set with the supervisor.
Coordinate and execution of the periodic re-validation studies in accordance with the schedule agreed upon with the supervisor, the Investigational Products Core, and the FDA.
Continuous examination and application of the advances in the fields of manufacturing equipment technology and computerization to the radiopharmaceutical production.
Develop, manage, and optimization of radiopharmaceutical manufacturing process automation.
Manufacture the radiopharmaceuticals in complete conformance with the approved Standard Operating Procedures (SOP's).
Ensure the availability of approved and appropriately labeled reagents and materials required for the clinical radiopharmaceutical manufacturing and QC
Master's Degree in Chemistry and 1-2 years of professional experience #LI-POST
MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.
Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.
Internal Number: 9123128
About Memorial Sloan-Kettering Cancer Center
As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, and superb educational programs. The close collaboration between our physicians and scientists is one of our unique strengths, enabling us to provide patients with the best care available today as we work to discover more effective strategies to prevent, control, and ultimately cure cancer in the future. Our education programs train future physicians and scientists, and the knowledge and experience they gain at Memorial Sloan-Kettering has an impact on cancer treatment and the biomedical research agenda around the world.