Summary
The Principal Scientist, Radiopharmaceutical Development/CMC will play a key role in driving pre-clinical, early-, and late-stage development and lifecycle management of radiopharmaceuticals for clinical use. As a scientific and technical leader, this individual will be instrumental in advancing RayzeBio's innovative drug products from bench to clinic and beyond.
The Principal Scientist will provide leadership across multiple stages of drug development — including formulation development and optimization, IND-enabling studies, and scale-up and automation development — while collaborating cross-functionally with discovery, pharmacology, CMC, toxicology, and clinical teams to accelerate novel therapeutics toward patients in need.
Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
- 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
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision and distance vision.
This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment _with radioactive materials_.
Work EnvironmentThe noise level in the work environment is usually moderate.
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