Sr. Scientist, Radiopharmaceutical Development

Role Summary

The Sr. Scientist, Radiopharmaceutical Development is a leading contributor in the design, development, and advancement of RayzeBio's radiopharmaceutical programs. This senior role is responsible for driving innovative research in novel isotope and chelator development, translating cutting-edge scientific discoveries into robust clinical drug products. The Sr. Scientist will lead CMC radiopharmaceutical process development, oversee IND-enabling activities, and play a pivotal role in clinical manufacturing. This position demands expertise in radiochemical synthesis, analytical techniques, and radiopharmaceutical formulation, as well as a proven ability to manage complex projects and mentor junior staff.

Responsibilities

• Process Development & Scale-Up: Drive CMC process development and optimization for clinical drug products, including formulation lock and robust process definition, ensuring scalability and compliance with regulatory standards.
• Technology Transfer: Lead the transfer of advanced radiopharmaceutical processes and technologies to internal and external manufacturing sites, including the Indianapolis facility and CDMO partners.
• Laboratory Oversight: Oversee the development, operation, and maintenance of radiochemistry laboratory infrastructure, ensuring readiness for translational activities from preclinical through clinical phases.
• Collaboration: Foster collaborative relationships with discovery scientists, external academic partners, and CDMOs to address complex scientific questions and pursue joint research efforts.
• Lead Research Initiatives: Independently design and execute advanced radiochemistry and radiolabeling experiments, with a special focus on novel radioisotope and chelator development to enable new classes of radiopharmaceuticals.
• Technical Leadership: Serve as a subject matter expert in radiopharmaceutical production processes, quality control, and advanced analytical methodologies. Provide scientific leadership across multidisciplinary teams.
• Innovation in Isotope and Chelator Chemistry: Direct research into the identification, synthesis, and characterization of novel isotopes and chelators to enhance therapeutic and diagnostic radiopharmaceutical properties.
• Safety & Compliance: Ensure strict adherence to radiation safety protocols, federal and state regulations, and internal guidelines for handling radioactive materials; promote a culture of safety-first and regulatory compliance.
• Data Analysis & Reporting: Interpret complex experimental data, draw scientifically rigorous conclusions, and communicate findings in technical reports, regulatory documentation, and presentations for internal and external stakeholders.
• Project Management & Mentorship: Manage and prioritize research projects, oversee third-party vendors, and mentor junior scientists and associates.
• Documentation: Draft and review CMC sections for regulatory submissions, SOPs, and comprehensive development reports.
• Travel: Less than 10% travel required, including external research sites and manufacturing facilities.

Qualifications

• BSc +7 years, MSc + 5 years or PhD +3 years in Chemistry, Radiochemistry, Pharmaceutical Sciences, or related field with relevant industry experience, including significant work with radioactive materials, novel isotopes, and chelator chemistry.
• Demonstrated expertise in radiochemical synthesis, purification, formulation, and analytical techniques.
• Proven track record of innovation in radiopharmaceutical development, including novel isotope and chelator research.
• Deep familiarity with federal and state regulatory requirements and safety protocols for radioactive materials.

Skills

• Advanced experience developing stable radiopharmaceutical formulations with targeted attributes such as extended shelf-life, radiochemical purity, and enhanced bio-distribution.
• Hands-on expertise with commercial and custom radiopharmaceutical manufacturing and analytical equipment systems, including automation platforms, radioHPLC, radioTLC, gamma counters, dose calibrators, hot cell manipulators, and advanced gamma spectroscopy.
• Extensive experience with a broad spectrum of radioactive materials for both diagnostic and therapeutic applications.
• Strong professional ethics, integrity, and ability to maintain confidential information.
• Outstanding written and verbal communication skills, with the ability to influence and communicate effectively across all levels, including executive leadership.
• Proactive, innovative thinker who thrives in a fast-paced, multi-disciplinary industrial environment.
• Demonstrated ability to manage complex research projects and mentor junior staff.

Education

• BSc +7 years, MSc + 5 years or PhD +3 years in Chemistry, Radiochemistry, Pharmaceutical Sciences, or related field with relevant industry experience, including significant work with radioactive materials, novel isotopes, and chelator chemistry.

Additional Requirements

• Physical Demands: Regularly required to sit, reach with hands and arms, and talk or hear. Occasional lifting and/or moving up to 30 pounds may be required. Lab work requires use of protective clothing, gloves, and safety glasses. Laboratory environment with moderate noise levels; strict adherence to safety protocols for working with radioactive materials is required.