Scientist, Radiopharmaceutical Development & CMC

Bristol Myers Squibb•Indianapolis, IN

7d•Onsite

About The Position

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. Read more: careers.bms.com/working-with-us . 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 Scientist in our team to support development and optimization of radiopharmaceutical drug products and radioisotopes. This role is critical to advancing our preclinical development, Chemistry, Manufacturing, and Controls (CMC) strategy and ensuring successful technology transfer to clinical and commercial manufacturing sites.

Requirements

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

Responsibilities

Design, plan and execute scientific experiments for pre-clinical development of radiopharmaceuticals.
Drive and support CMC process development and optimization for clinical drug products, including formulation lock and robust process definition, ensuring scalability and compliance with regulatory standards
Technology transfer of drug products and API from preclinical stage to clinical manufacturing.
Support lifecycle management of radiopharmaceuticals from IND to commercial approval
Interpret complex experimental data, draw scientifically rigorous conclusions, and communicate findings in technical reports, regulatory documentation, and presentations for internal and external stakeholders
Review and author technical reports and source documents to support regulatory filing.
Review and 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
Up to 20% of travel required

Benefits

Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K).
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Other perks like tuition reimbursement and a recognition program.

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