Jobs at Mariana Oncology

Support analytical method development, optimization, qualification, transfer, and routine testing for radiopharmaceuticals. Perform testing using HPLC, LC-MS, ICP-MS, GC, TLC, and gamma spectroscopy; troubleshoot methods and investigate unexpected results. Document compliant, data-integrity-focused analytical work, support stability studies and regulatory requirements, collaborate with CMC, process development, quality, radiochemistry, and external partners, and communicate results through reports and presentations.

Develop and optimize radiolabeling methods and formulations for radiopharmaceutical candidates. Conduct product analysis, stability testing, in vitro studies, biodistribution, efficacy, pharmacokinetic, and preclinical imaging studies. Collaborate cross-functionally, present research findings, prepare technical reports, maintain compliant laboratory records, follow SOPs and EHS standards, and potentially manage CRO activities.

Lead QA oversight for radioligand therapy GMP manufacturing operations, ensuring compliance with cGMP, radiation safety, and global quality standards. Manage batch review and release, deviations, CAPAs, audits/inspections, QA training, SOPs, and cross-functional quality governance to maintain inspection-ready radiopharmaceutical production.

Serve as process subject matter expert for assigned pharmaceutical manufacturing technologies. Provide front-line shop-floor technical support, lead deviations/investigations and CAPAs, drive process characterization and technology transfer, support equipment qualification, maintain inspection readiness, develop training, and collaborate with CMC/radiochemistry and Quality to ensure robust, compliant clinical and commercial production.