Work Location: New Haven County, Connecticut

Summary:

The Senior Radiochemist will play a key role in leading technology transfer activities for radiopharmaceutical processes, ensuring compliance with regulatory standards, and supporting production and quality control. This position requires expertise in radiochemistry, process validation, and cross-functional collaboration to optimize and implement radiochemical synthesis and analytical methods.

Responsibilities:

• Direct and coordinate technology transfer for radiopharmaceutical processes, including transitions from research to GMP manufacturing and between different sites.
• Design and implement comprehensive technology transfer plans, protocols, and reports in accordance with regulatory guidelines.
• Supervise and optimize analytical method development, validation, and process validation activities.
• Provide technical support for the production and quality control of PET radiopharmaceuticals.
• Maintain strict adherence to GMP, FDA, and other regulatory requirements throughout transfer and manufacturing processes.
• Collaborate with cross-functional teams in process development, quality assurance, regulatory affairs, and project management.
• Identify, troubleshoot, and enhance radiochemical synthesis processes and analytical methodologies.
• Deliver training and ensure effective knowledge transfer and documentation for receiving site personnel.

Qualifications:

• Ph.D. in Radiochemistry, Organic Chemistry, or a related field (Master’s degree with significant experience may be considered).
• At least 5 years of experience in Fluorine-18 radiopharmaceutical production or a closely related area.
• Proven experience in technology transfer, process validation, or scale-up within a GMP environment.
• Comprehensive knowledge of GMP and regulatory standards for radiopharmaceuticals.
• Hands-on expertise with automated synthesis modules and analytical techniques such as HPLC and GC.
• Demonstrated ability to troubleshoot and optimize complex radiochemical processes.
• Excellent communication skills for effective cross-site and cross-functional collaboration.
• Strong organizational skills with the ability to manage multiple projects independently in a dynamic setting.
• Willingness and ability to travel domestically and internationally (estimated 20-40%).
• Experience supporting IND/NDA submissions or regulatory inspections is a plus.
• Familiarity with clinical manufacturing and multi-site operations is advantageous.
• Flexibility to support intensive, on-site activities during technology transfer phases.
• Ability to work across multiple time zones and with international teams.
• Comfortable adapting to evolving processes, timelines, and priorities.
• Willingness to participate in hands-on laboratory and manufacturing activities, including troubleshooting and on-the-floor support during critical operations.

Published Category: Manufacturing & Technical Operations