Scientist I/II, CMC Radiochemistry

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 production procedures 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:

• A Ph.D. in Inorganic Chemistry, Organic Chemistry, Radiochemistry, or related discipline and 0+ years of Biotech or Pharmaceutical industry experience; BS or MS in Chemistry or related discipline and 4 – 6+ years of Biotech or Pharmaceutical industry experience.
• Radiopharmaceutical drug substance and drug product development experience is a plus.
• Development experience for the biologics and peptides GMP manufacturing is a plus.
• A strong background and in-depth working knowledge of biologics and peptides and conjugates analysis, including but not limited to: Assay and Purity (RP-HPLC, IP-RP-HPLC, AEX/CEX-HPLC), with LC-MS and LC-ICP-MS experience being a plus.
• Knowledgeable in regulatory requirements and guidelines (cGMP, ICH, FDA, and USP, EP) with the ability to apply to the Phase appropriate pharmaceutical development. GMP pharmaceuticals validation experience is a plus.
• Experience with regulatory documentation is preferred.
• Understanding of chemistry manufacturing and controls (CMC) documentation for novel compounds consistent with requirements for IND, NDA, or other regulatory pathways.
• Good understanding of the radiation safety regulations and guidelines is preferred.
• Strict adherence to data integrity is required.
• Proven ability to adhere to good documentation standards and maintain detailed records of all work performed.
• Excellent verbal and written communication skills.

Mariana Oncology’s Values

• Building a Legacy
• Execution Excellence
• Courage of our Convictions