Sr Scientist – Radiopharmaceutical Development & CMC Full-time

Sr. Scientist

Working with Us Challenging. Meaningful. Life-changing. Those aren't 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. You'll 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.

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.

Education and Experience

Ph.D., M.S., or B.S. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field, with requisite industry experience. 5+ years of experience in drug development, manufacturing, CMC or related fields in a pharmaceutical industry, preferably radiopharmaceuticals.

Skills and Qualifications

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

Physical Demands

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision and distance vision. This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.

Work Environment

The noise level in the work environment is usually moderate.

#RayzeBio, #LI-Onsite

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.