Scientist I / II, CMC Radiochemistry

Job Description

Job Description

Salary : Reporting :

Principal Scientist, CMC Radiochemistry

Description :

We are seeking an experienced Scientist I / II, CMC Radiochemistry to join Mariana Oncology's CMC organization, advancing personalized medicine and radiopharmaceuticals. You will be responsible for radiochemistry development through validations of pipeline projects leading to and enabling production, development, and advancement of radiotherapeutics and nuclear imaging probes. You will join the development efforts in support of the next generation radiotherapeutics for Mariana Oncology's clinical trial programs.

Illustrative Breadth of Responsibilities :

• Radiolabeling / coordination chemistry process, analytical development and troubleshooting with a broad range of radioisotopes, including but not limited to : Lu-177, Ac-225, Zr-89, Cu-64, In-111, Ga-68 and Pb-212.
• Early formulation development, process and analytical method optimization to ensure drug product stability.
• Participate in the development and process validation of radiopharmaceutical productionprocedures for use in preclinical and clinical studies.
• Support CMC drafting and executing Master Batch Records, protocols for validation of manufacturing processes of radiopharmaceuticals, validation of analytical methods.
• Participate and support CMC analytical development, method validation, and reporting activities, including but not limited to Identity, Purity, Impurities and Assays.
• Support CMC in preparation of method validation protocols, execution of method validations, and authoring / review of reports, SOPs, and other technical documents for technical correctness, quality, and regulatory compliance.
• Perform analysis, tabulating and gathering data for CMC sections (Module 3), development reports for IND and IMPD, to regulatory agencies including FDA and EMEA.
• Support team communications in disseminating results, which may come in the form of presentations or reports.
• Contribute to the organization and maintenance of the laboratory.

Requirements / Skills :

Mariana Oncologys Values