Scientist, Radiopharmaceutical Development & CMC

Role Summary

We are seeking a highly motivated Scientist in our team to support development and optimization of radiopharmaceutical drug products and radioisotopes. This role is critical to advancing our preclinical development, Chemistry, Manufacturing, and Controls (CMC) strategy and ensuring successful technology transfer to clinical and commercial manufacturing sites.

Responsibilities

• Design, plan and execute scientific experiments for pre-clinical development of radiopharmaceuticals.
• Drive and support CMC process development and optimization for clinical drug products, including formulation lock and robust process definition, ensuring scalability and compliance with regulatory standards
• Technology transfer of drug products and API from preclinical stage to clinical manufacturing.
• Support lifecycle management of radiopharmaceuticals from IND to commercial approval
• Interpret complex experimental data, draw scientifically rigorous conclusions, and communicate findings in technical reports, regulatory documentation, and presentations for internal and external stakeholders
• Review and author technical reports and source documents to support regulatory filing.
• Review and 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
• Up to 20% of travel required

Qualifications

• Required: Ph.D., M.S., or B.S. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field, with requisite industry experience.
• Required: 3+ years of experience in drug development, manufacturing, CMC or related fields in a pharmaceutical industry, preferably radiopharmaceuticals.

Skills

• 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.

Education

• Ph.D., M.S., or B.S. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field, with requisite industry experience.

Additional Requirements

• Physical Demands: 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 include close and distance vision. This position requires working in a laboratory environment with protective clothing, gloves, and safety glasses, and handling radioactive materials.