Principal Scientist, Radiopharmaceutical Development/CMC

Job Responsibilities

• Provide scientific and technical leadership across RayzeBio's drug product development platform, driving end-to-end process development, scale-up, and the translation of novel processes into robust, repeatable GMP manufacturing operations.
• Lead, design, plan, and execute scientific experiments supporting the development, scale-up, and automation of radiopharmaceutical drug product and API manufacturing processes.
• Drive the technology transfer of drug products and APIs from preclinical through clinical manufacturing stages, ensuring seamless transitions and sustained process continuity.
• Partner with Engineering and Operations to define user requirements and technical specifications, influence equipment design and selection for drug product manufacturing.
• Investigate manufacturing gaps and deviations through rigorous root cause analysis, leading the development and execution of corrective actions and continuous process improvement initiatives.
• Author technical reports, development summaries, and source documents to support regulatory filings, including CMC sections for IND and NDA submissions to the FDA, as well as filings for international regulatory jurisdictions (e.g., EMA, Health Canada).
• Collaborate cross-functionally with Regulatory, Quality, Supply Chain, Clinical, and R&D teams to ensure scientific and operational alignment with program milestones and corporate objectives.
• Mentor and develop junior scientists, fostering a culture of scientific excellence, continuous learning, and operational rigor.
• Support commercialization activities for radiopharmaceutical products, contributing to the successful transition from clinical to commercial-scale manufacturing.
• Travel up to 20% as required to support program needs and site activities.

Education And Experience

• Ph.D., M.S., or B.S. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field, with requisite industry experience.
• 8+ years of experience in drug development, manufacturing, CMC or related fields in a pharmaceutical industry, preferably radiopharmaceuticals.
• Demonstrated experience in radiopharmaceutical formulation development, process development, and GMP manufacturing.
• Proven track record of leading and executing IND-enabling studies and supporting regulatory submissions (IND, NDA, or equivalent).
• Experience with technology transfer from preclinical to clinical manufacturing environments.
• Working knowledge of GMP regulations (FDA, EMA, ICH guidelines) and NRC regulatory requirements.
• Experience working in hot cell environments and with automated synthesis platforms is highly desirable.

Skills And Qualifications

• Strong understanding of GMP, FDA/EMA regulations, and ICH guidelines.
• Strong problem-solving abilities and the ability to manage multiple projects in a fast-paced environment.
• Excellent project management and cross-functional collaboration skills.
• Excellent technical writing skills.
• Experience with alpha/gamma emitting radionuclides.
• Applies AI to improve team execution and decision-making.

Physical Demands

• Sit, reach with hands and arms, and talk or hear.
• Occasionally lift and/or move up to 15 pounds.

Work Environment

• Noise level in the work environment is usually moderate.
• Laboratory environment with protective clothing, gloves, and safety glasses required while working with radioactive materials.