Senior Manager, Radiopharmaceutical Development/CMC

Bristol-Myers Squibb Co; Indianapolis (IN); On-site; USD 124,000 - 151,000; Full time

Job summary

RayzeBio in Indianapolis is seeking a Senior Manager, Radiopharmaceutical Development/CMC to lead end-to-end drug product development, formulation optimization, IND-enabling studies, and scale-up for GMP manufacturing of radiopharmaceuticals.

You will coordinate cross-functionally with discovery, CMC, regulatory, quality, and clinical teams to advance projects from bench to clinic while mentoring scientists and contributing to regulatory filings.

Qualifications

• Ph.D., M.S., or B.S. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.
• 8+ years in drug development/manufacturing/CMC in pharma, preferably radiopharmaceuticals.
• Experience with IND-enabling studies and regulatory submissions (IND/NDA).
• Experience with technology transfer from preclinical to clinical manufacturing.

Responsibilities

• Provide leadership across RayzeBio's drug product development, scaling, and GMP manufacturing operations.
• Lead and execute scientific experiments for radiopharmaceutical drug product development and API manufacturing.
• Drive technology transfer across development stages ensuring seamless transitions.
• Collaborate with Engineering/Operations to define specs and equipment design.
• Investigate deviations and drive corrective actions and continuous improvement.
• Prepare technical reports and regulatory documents (CMC sections for FDA/EMA submissions).
• Coordinate with Regulatory, Quality, Supply Chain, Clinical, and R&D teams to meet milestones.
• Mentor junior scientists and foster scientific excellence.
• Support commercialization activities for radiopharmaceutical products.

Skills

GMP regulations knowledge

Project management

Cross-functional collaboration

Technical writing

Radiopharmaceuticals experience

AI to improve execution

Education

Ph.D., M.S., or B.S. in Chemistry/ Chemical Engineering/ Pharmaceutical Sciences

Tools

Automated synthesis platforms

Hot cell environments

Job description

Life at BMS

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/

The Senior Manager (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 Senior Manager (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 Responsibilities

Essential 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

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Indianapolis - RayzeBio - IN: $124,449 - $150,803

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

RayzeBio and Bristol Myers Squibb

RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.

Supporting People with Disabilities

BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS and RayzeBio will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1603030 : Senior Manager, Radiopharmaceutical Development/CMC