Production Chemist

Production ChemistSchedule: Monday-Friday, 8:00 AM-4:30 PM (Overtime as needed)Position SummaryThe 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.Key ResponsibilitiesManufacture 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.Maintain Class I Radiation Worker qualifications.Assist with general laboratory housekeeping and support additional projects as assigned.QualificationsBachelor'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.Core CompetenciesStrong problem-solving and technical troubleshooting skillsEffective decision-making and leadership abilitiesTechnical writing and documentation proficiencyAttention to detail and organizational skillsCollaborative, team-oriented mindset

Created: 2026-04-03