Sr. Scientist, Radiopharmaceuticals - Indianapolis, IN

VetJobs; Indianapolis (IN); On-site; USD 108,000 - 131,000; Full time

Job summary

RayzeBio, a Bristol Myers Squibb subsidiary, seeks a Sr. Scientist, Radiopharmaceuticals to advance preclinical development, CMC, and regulatory filings across multiple teams. You will drive development and commercialization programs for drug products and radioisotopes, mentor junior staff, and ensure regulatory alignment.

You will also contribute to technology transfer, scale-up, and automation of manufacturing processes, with travel up to 20% as needed in a fast-paced lab environment.

Qualifications

• Ph.D., M.S., or B.S. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field, with requisite industry experience.
• 5+ years of experience in drug development, manufacturing, CMC or related fields in a pharmaceutical industry, preferably radiopharmaceuticals.
• Strong GMP, FDA/EMA regulations, and ICH guidelines knowledge.

Responsibilities

• Design, plan and execute scientific experiments for preclinical development of radiopharmaceuticals.
• Drive CMC process development and optimization for clinical drug products, including formulation lock and robust process definition, ensuring scalability and regulatory compliance.
• Lead technology transfer of drug products and API from preclinical stage to clinical manufacturing.
• 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.
• 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
• Uses AI tools to enhance individual productivity and quality of work
• Up to 20% of travel required

Education

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

Job description

Job Description

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

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.

The Sr. Scientist, Radiopharmaceuticals will be responsible for advancing scientific and technical projects across various scientific, production, operations, quality and regulatory teams, to support development and commercialization of radiopharmaceuticals. Responsibilities include driving preclinical development, Chemistry Manufacturing and Control (CMC), development and commercialization programs for drug products and radioisotopes.

Job Responsibilities

• Design, plan and execute scientific experiments for preclinical 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
• Lead technology transfer of drug products and API from preclinical stage to clinical manufacturing.
• 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.
• 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
• Uses AI tools to enhance individual productivity and quality of work
• Up to 20% of travel required

Auto req ID

483093BR

Minimum Education Required

Bachelors

Additional Qualifications/Responsibilities

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.

Compensation Overview

Indianapolis - RayzeBio - IN: $107,904 - $130,754

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.

City

Indianapolis

State

Indiana

Job Category

Scientific Research & Development

Job Code

Pharmaceutical Pharmaceutical

Affiliate Sponsor

Bristol Myers Sqibb BMS

Salary Range

>$100,000