Principal Scientist, Radiopharmaceutical Development/CMC

Job description

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/ SummaryThe Principal Scientist, Radiopharmaceutical Development/CMC will play a key role in driving pre-clinical, early-, and late-stage development and lifecycle management of radiopharmaceuticals for clinical use. As a scientific and technical leader, this individual will be instrumental in advancing RayzeBio's innovative drug products from bench to clinic and beyond. The Principal Scientist will provide leadership across multiple stages of drug development — including formulation development and optimization, IND-enabling studies, and scale-up and automation development — while collaborating cross-functionally with discovery, pharmacology, CMC, toxicology, and clinical teams to accelerate novel therapeutics toward patients in need. Job ResponsibilitiesEssential duties and responsibilities include the following. Other duties may be assigned. ·Provide scientific and technical leadership across RayzeBio's drug product development platform, driving end-to-end process development, scale-up, and the translation of novel processes into robust, repeatable GMP manufacturing operations. ·Lead, design, plan, and execute scientific experiments supporting the development, scale-up, and automation of radiopharmaceutical drug product and API manufacturing processes. ·Drive the technology transfer of drug products and APIs from preclinical through clinical manufacturing stages, ensuring seamless transitions and sustained process continuity. ·Partner with Engineering and Operations to define user requirements and technical specifications, influence equipment design and selection for drug product manufacturing. ·Investigate manufacturing gaps and deviations through rigorous root cause analysis, leading the development and execution of corrective actions and continuous process improvement initiatives. ·Author technical reports, development summaries, and source documents to support regulatory filings, including CMC sections for IND and NDA submissions to the FDA, as well as filings for international regulatory jurisdictions (e.g., EMA, Health Canada). ·Collaborate cross-functionally with Regulatory, Quality, Supply Chain, Clinical, and R&D teams to ensure scientific and operational alignment with program milestones and corporate objectives. ·Mentor and develop junior scientists, fostering a culture of scientific excellence, continuous learning, and operational rigor. ·Support commercialization activities for radiopharmaceutical products, contributing to the successful transition from clinical to commercial-scale manufacturing. ·Travel up to 20% as required to support program needs and site activities. Education and Experience·Ph.D., M.S., or B.S. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field, with requisite industry experience. ·8+ years of experience in drug development, manufacturing, CMC or related fields in a pharmaceutical industry, preferably radiopharmaceuticals. ·Demonstrated experience in radiopharmaceutical formulation development, process development, and GMP manufacturing. ·Proven track record of leading and executing IND-enabling studies and supporting regulatory submissions (IND, NDA, or equivalent). ·Experience with technology transfer from preclinical to clinical manufacturing environments. ·Working knowledge of GMP regulations (FDA, EMA, ICH guidelines) and NRC regulatory requirements. ·Experience working in hot cell environments and with automated synthesis platforms is highly desirable. 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. ·Experience with alpha/gamma emitting radionuclides. ·Applies AI to improve team execution and decision‑making 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. #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. Compensation Overview: Indianapolis - RayzeBio - IN: $124,449 - $150,803 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. ​Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remot