Sr Scientist Radiopharmaceutical Development & CMC Indianapolis,IN

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Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives.

RayzeBio a Bristol Myers Squibb company is a dynamic biotechnology company headquartered in San Diego CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team RayzeBio aims to be the global leader in radiopharmaceuticals.



Summary

We are seeking a highly motivated Sr. Scientist to lead the development and optimization of radiopharmaceutical drug products and radioisotopes. This position plays a pivotal role in driving preclinical development of innovative drug products aimed at treating various cancers. The successful candidate will contribute to shaping and advancing our Chemistry Manufacturing and Controls (CMC) strategy

Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

Design plan and execute scientific experiments for pre-clinical development of radiopharmaceuticals.

Drive CMC process development and optimization for clinical drug products including formulation lock and robust process definition ensuring scalability and compliance with regulatory standards

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.

Support technology transfer of drug products and API from preclinical stage to clinical manufacturing.

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

Up to 20% of travel required