Clinical Radiochemist

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Exciting Opportunity at MSK: Our Radiochemistry & Molecular Imaging Probes team is seeking an experienced Clinical Radiochemist to join our team! The position requires the ability to successfully translate new and existing radiopharmaceutical agents from the preclinical setting to routine manufacturing for clinical use. Extensive focus on routine manufacturing of radiopharmaceuticals, manufacturing process optimization, quality control testing, and technician training. This position will collaborate and integrate 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, 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 RMIP lead nuclear pharmacist.

The position requires experience in translation and transference of new and/or existing radiopharmaceutical agents from the preclinical to GMP manufacturing for clinical use. Focus manufacturing process optimization, manual radiolabeling process development, automation, QC analytical method development, and documentation. This position will work in a multidisciplinary setting, often will collaborate with research radiochemists, molecular imaging scientists, and radiopharmacists. A deep knowledge of GDP and cGMP/ICH regulations in manufacturing and performing QC analysis is necessary to assure safe and reliable clinical production of radiopharmaceutical agents. Significant responsibility for the radiolabeling process development and optimization, analytical method development and validation, compliance with the existing cGMP system, CMC generation assistance, and any other subject deemed appropriate by the Supervisor. The work schedule is determined by the clinical dose schedule. Therefore, the ability to work outside of regular working hours is required.

Role Overview:

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

Qualifications:

• Bachelor's Degree or higher in Chemistry and 1-2 years of CDMO business

Additional Information:

• Hours: 9 AM - 5 PM
• Location: Schwartz, MSKCC, NYC

Pay Range: $41.18-$65.85

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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.

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