Pay Range$41.18-$65.85Company OverviewThe people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursue our mission at MSK and around the globe. Please review important announcements about vaccination requirements and our upcoming EHR implementation by clicking here (https://careers.mskcc.org/frequently-asked-questions/) . Important Note for MSK Employees: Your Career Hub profile is submitted to the hiring team as your internal resume. Please be sure your profile is fully complete with your skills, relevant experience and education (if required). Click here (https://mskcc.sharepoint.com/sites/pub-hr/SitePages/Career-Hub.aspx) to learn more. Please note, this link is only accessible for MSK employees. Job DescriptionExciting Opportunity at MSK:Our Radiochemistry & Molecular Imaging Probes team is seeking an experiencedClinical Radiochemistto 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
Helpful Links:
MSK Compensation Philosophy (https://careers.mskcc.org/frequently-asked-questions/)
Review Our Greats Benefits Offerings
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ClosingMSK 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. Stay in touch!Register now to join Memorial Sloan Kettering’sTalent Community (https://externaltalent-mskcc.icims.com/connect?back=intro&iniframe=1&hashed=-435744324) to receive inside information on our organization and new job opportunities.Job LocationsUSA-NY-New YorkPosted Date8 hours ago(12/16/2024 11:03 AM)Requisition ID 2024-82710 Category Research - Laboratory Pay Range $41.18-$65.85
