Senior Scientist, Radiopharmaceutical Development & CMC

JIT Global Freight Solution P Ltd; Indianapolis (IN); On-site; USD 107,904 - 130,754; Full time

Benefits offered by this job

Medical, pharmacy, dental

401(k)

Paid holidays

Job summary

Bristol Myers Squibb is seeking a Sr. Scientist to lead development and optimization of radiopharmaceutical drug products and radioisotopes at Indianapolis, IN. The role drives preclinical development and shapes the CMC strategy for regulatory filings.

The position requires a Ph.D./MS/BS in a related field and 5+ years in drug development with GMP/regulatory experience. Travel up to 20% may be needed.

Qualifications

• Ph.D., MS, or BS in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.
• 5+ years of drug development, manufacturing, CMC or related pharma experience (radiopharmaceuticals preferred).
• Experience with GMP and regulatory guidelines.

Responsibilities

• 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 regulatory compliance.
• 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.

Skills

GMP knowledge

FDA/EMA regulations

ICH guidelines

Problem-solving

Project management

Cross-functional collaboration

Technical writing

Education

Ph.D., MS, or BS in Chemistry/related field

Job description

Bristol Myers Squibb is seeking a Sr. Scientist to lead development and optimization of radiopharmaceutical drug products and radioisotopes at Indianapolis, IN. The role drives preclinical development and shapes the CMC strategy for regulatory filings.

The position requires a Ph.D./MS/BS in a related field and 5+ years in drug development with GMP/regulatory experience. Travel up to 20% may be needed.