Senior Radiopharmaceutical Scientist: Preclinical & CMC Lead

VetJobs; Indianapolis (IN); On-site; USD 108,000 - 131,000; Full time

Job summary

RayzeBio, a Bristol Myers Squibb subsidiary, seeks a Sr. Scientist, Radiopharmaceuticals to advance preclinical development, CMC, and regulatory filings across multiple teams. You will drive development and commercialization programs for drug products and radioisotopes, mentor junior staff, and ensure regulatory alignment.

You will also contribute to technology transfer, scale-up, and automation of manufacturing processes, with travel up to 20% as needed in a fast-paced lab environment.

Qualifications

• Ph.D., M.S., or B.S. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field, with requisite industry experience.
• 5+ years of experience in drug development, manufacturing, CMC or related fields in a pharmaceutical industry, preferably radiopharmaceuticals.
• Strong GMP, FDA/EMA regulations, and ICH guidelines knowledge.

Responsibilities

• Design, plan and execute scientific experiments for preclinical development of radiopharmaceuticals.
• Drive CMC process development and optimization for clinical drug products, including formulation lock and robust process definition, ensuring scalability and regulatory compliance.
• Lead technology transfer of drug products and API from preclinical stage to clinical manufacturing.
• Design, plan and execute scientific experiments for scale up and automation of drug products and API manufacturing processes.
• Interpret complex experimental data, draw scientifically rigorous conclusions, and communicate findings in technical reports, regulatory documentation, and presentations for internal and external stakeholders.
• Author technical reports and source documents to support regulatory filing.
• Author CMC sections for IND/NDA for FDA submissions, and support regulatory filing in other jurisdictions, e.g. EMA, Health Canada, etc.
• Collaborate cross-functionally with Regulatory, Quality, Supply Chain, Clinical, and R&D teams to ensure alignment with corporate goals
• Manage and prioritize research projects, oversee third-party vendors, and mentor junior scientists and associates
• Provide support for commercialization of radiopharmaceuticals
• Uses AI tools to enhance individual productivity and quality of work
• Up to 20% of travel required

Education

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

Job description

RayzeBio, a Bristol Myers Squibb subsidiary, seeks a Sr. Scientist, Radiopharmaceuticals to advance preclinical development, CMC, and regulatory filings across multiple teams. You will drive development and commercialization programs for drug products and radioisotopes, mentor junior staff, and ensure regulatory alignment.

You will also contribute to technology transfer, scale-up, and automation of manufacturing processes, with travel up to 20% as needed in a fast-paced lab environment.