Senior Radiopharmaceutical Scientist - Preclinical & CMC Lead

Bristol Myers Squibb; Indianapolis (IN); On-site; USD 108,000 - 131,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

160 hours paid vacation annually

Global Shutdown between Christmas and

Job summary

RayzeBio, an independent subsidiary of Bristol Myers Squibb, is seeking a Sr. Scientist, Radiopharmaceuticals in Indianapolis to advance preclinical and CMC programs and support regulatory filings.

You will collaborate across Regulatory, Quality, Supply Chain, Clinical and R&D to drive technology transfer and scale-up, with up to 20% travel. The role requires advanced chemistry/engineering qualifications (PhD/MS/BS) and 5+ years in drug development or radiopharmaceuticals.

Qualifications

• Strong understanding of GMP, FDA/EMA regulations, and ICH guidelines.
• Ability to manage multiple projects in a fast-paced environment.
• Excellent project management and cross-functional collaboration skills.
• Excellent technical writing skills.

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.
• 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

Skills

GMP understanding

Regulatory knowledge

Problem solving

Project management

Cross-functional collaboration

Technical writing

Education

Ph.D./M.S./B.S. in Chemistry/Engineering/Pharmaceuticals

Job description

RayzeBio, an independent subsidiary of Bristol Myers Squibb, is seeking a Sr. Scientist, Radiopharmaceuticals in Indianapolis to advance preclinical and CMC programs and support regulatory filings.

You will collaborate across Regulatory, Quality, Supply Chain, Clinical and R&D to drive technology transfer and scale-up, with up to 20% travel. The role requires advanced chemistry/engineering qualifications (PhD/MS/BS) and 5+ years in drug development or radiopharmaceuticals.