Radiopharmaceutical Development Lead – CMC & IND Enablement

Biopharma Careers; Indianapolis (IN); On-site; USD 124,000 - 151,000; Full time

Benefits offered by this job

Health Coverage

401(k) Plan

Paid Time Off

Summer hours / Flexible benefits

Job summary

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks a Principal Scientist, Radiopharmaceutical Development/CMC to lead end-to-end development from bench to clinic. The role drives formulation, scale-up, tech transfer, and regulatory filing support across cross-functional teams in oncology radiopharmaceuticals.

You will mentor scientists, collaborate with Regulatory, Quality, and Clinical teams, and contribute to commercialization efforts while traveling up to 20% for program needs.

Qualifications

• Ph.D., M.S., or B.S. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.
• 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.

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.

Skills

GMP knowledge

Regulatory knowledge

Project management

Cross-functional collaboration

Technical writing

AI in teams

Education

PhD/MS/BS in Chemistry/ Chemical Engineering/ Pharmaceutical Sciences

Tools

Automated synthesis platforms

Hot cell environments

GMP manufacturing equipment

Job description

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks a Principal Scientist, Radiopharmaceutical Development/CMC to lead end-to-end development from bench to clinic. The role drives formulation, scale-up, tech transfer, and regulatory filing support across cross-functional teams in oncology radiopharmaceuticals.

You will mentor scientists, collaborate with Regulatory, Quality, and Clinical teams, and contribute to commercialization efforts while traveling up to 20% for program needs.