Jobs at Mariana Oncology

• Leadership and Training

Lead the QA RLT Operations team.
Coach and develop QA RLT Operations team members, fostering a culture of quality, accountability, collaboration, and continuous improvement.
Serve as a subject matter expert (SME) in radiopharmaceutical GMP requirements, aseptic operations, and radiation-handling quality considerations.
Train manufacturing and QC personnel on quality systems, deviations, and compliance standards.
Support GMP training program by creating and delivering Operations QA training modules.

• Lead QA approval and oversight of qualification activities for GMP manufacturing equipment including:

Radiochemistry synthesis modules
Hot cells, isolators, and shielding systems
Automated dispensing and filling systems
Sterile filtration and aseptic processing equipment
HEPA/ventilation, HVAC, and radiation containment systems
Critical utilities (WFI, compressed gases, Environmental Monitoring /Building Management Systems-EMS/BMS)

• GMP Operations Oversight

Provide on-the-floor QA support for radioligand manufacturing, including aseptic processing, sterile filtration, radiolabeling, and final product packaging.
Perform line clearances, room/ equipment release, and real-time production record review.
Ensure adherence to GMP, ALCOA+ data integrity principles, and radiation safety requirements.