Position

Production Technology R&D Staff

Reporting to

Head of Clinical Trial Drug Manufacturing Department

Description

At Alpha Fusion, we are advancing the establishment of production technologies for the manufacture of clinical trial drugs under GMP conditions. Building on the manufacturing methods currently used for Phase 1 trials at Osaka University, we aim to improve these methods for future commercialization, achieve automation of At extraction and labeling processes, and ensure smooth technical transfer to our upcoming clinical trial drug GMP manufacturing facility.

Responsibilities

• Propose and maintain improvements to the process development testing environment.
• Under the direction of the Head of Clinical Trial Drug Manufacturing and the Head of Reliability Assurance, develop and implement production technology development plans, and prepare reports.
• Mainly collect baseline data for At pharmaceutical manufacturing methods (basis for process parameter settings) and automation conditions for extraction and labeling processes.
• Draft specifications for the procurement of necessary materials as instructed by the Head of Clinical Trial Drug Manufacturing.
• Collaborate with technical transfer counterparts to replicate manufacturing and quality control at the clinical trial drug manufacturing site based on internal data.

Requirements/Skills

• Experience in research and development, manufacturing, or quality control of radiopharmaceuticals.
• Experience and knowledge of clinical trial drug GMP, or experience in pharmaceutical manufacturing practice.
• Ability to understand and advance necessary tasks in English at a professional level.
• Experience in designing operation programs for automated synthesis devices.
• At least three years of job experience in chemical manufacturing process development in pharmaceutical companies, raw material manufacturing companies, or pharmaceutical manufacturing contract organizations.
• Experience in creating standard operating procedures and manufacturing records for clinical trial drugs.
• Qualifications related to the handling of radioactive materials.
• PET pharmacist..