Sr Scientist - Radiopharmaceutical Development & CMC at Bristol Myers Squibb Indianapolis

Sr Scientist – Radiopharmaceutical Development & CMC – Bristol Myers Squibb

Location:

Indianapolis, IN

We are seeking a highly motivated Sr. Scientist to lead the development and optimization of radiopharmaceutical drug products and radioisotopes. This position plays a pivotal role in driving preclinical development of innovative drug products aimed at treating various cancers and contributes to shaping and advancing our Chemistry, Manufacturing, and Controls (CMC) strategy.

• 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 such as EMA and Health Canada.
• 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% travel required.

• Ph.D., M.S., or B.S. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.
• 5+ 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.

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 position requires working in a laboratory environment; protective clothing, gloves, and safety glasses are required while working with radioactive materials.

Indianapolis – Rayze Bio – IN: $107,904 – $130,754 (Full‑time employee). Additional incentive cash and stock opportunities (based on eligibility) may be available. Final compensation is determined based on demonstrated experience.

• Medical, pharmacy, dental, and vision care.
• Well‑being support, employee assistance programs, financial well‑being resources, and 401(k).
• Short‑ and long‑term disability, life insurance, supplemental health insurance, business travel protection, and survivor support.
• Paid national holidays, optional holidays, Global Shutdown Days, up to 120 hours of paid vacation, 2 paid volunteer days, 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, and other resources.
• Tuition reimbursement and recognition program.

Bristol‑Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.