Production Chemist

Overview

Schedule: Monday 8:00 AM –4:30 PM (Overtime as needed)

The Senior Manufacturing Chemist is a key member of the production team responsible for manufacturing bulk radiopharmaceutical products in a highly regulated environment. This role supports production preparation, equipment maintenance, regulatory compliance, and continuous process improvement while ensuring safety, quality, and operational excellence.

• Manufacture radiopharmaceutical products in compliance with SOPs, cGMP, and regulatory requirements.
• Prepare production materials and supplies; manage production inventory.
• Perform routine production equipment maintenance and troubleshooting, including complex technical issues.
• Coordinate cross-functionally to meet manufacturing schedules and production targets.
• Author and revise SOPs, batch records, protocols, and technical documentation.
• Lead and support investigations including deviations, OOS events, CAPA, and Change Control activities.
• Drive continuous process improvement initiatives to enhance reliability, output, and radiation safety.
• Train and mentor Production Chemists as needed.
• Support cost-savings initiatives and help achieve departmental safety, quality, and financial metrics.
• Maintain regulatory compliance with U.S. and international agencies (FDA, NRC, EU, ISO, USP, etc.).
• Actively monitor and manage personal and team radiation exposure in accordance with established policies.
• Assist with general laboratory housekeeping and support additional projects as assigned.

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or related field required.
• Minimum 3 years of relevant manufacturing or production chemistry experience.
• Experience working in a GMP-regulated environment.
• Hands-on experience with chemistry-related production equipment.
• Familiarity with radiation protection and handling radioactive materials preferred.
• Experience with cyclotron solid targets, isotope dissolution, and separation preferred.
• Ability to work independently in a fast-paced, deadline-driven manufacturing environment.

• Strong problem-solving and technical troubleshooting skills
• Effective decision-making and leadership abilities
• Technical writing and documentation proficiency
• Attention to detail and organizational skills