Senior Radiochemist II, Technology Transfer

Position Overview

This is a full-time on site Senior Radiochemist II, Technology Transfer Specialist position based in our New Haven, Connecticut facility. The ideal candidate will lead the transfer of radiopharmaceutical manufacturing processes from development to GMP production, as well as between internal and external sites. In addition, this role will play a key role in leading new site start-up activities, ensuring successful implementation of radiopharmaceutical production capabilities.

This role requires deep expertise in radiochemistry, validation, and regulatory compliance, with a strong focus on ensuring robust, reproducible and inspection-ready manufacturing processes. This position requires domestic and international travel to support technology transfer activities at partner sites. Travel may be more frequent during the technology transfer phase.

About XingImaging:

XingImaging, a subsidiary of MITRO, is a leading provider of advanced research imaging and radiopharmaceutical services. Our New Haven facility offers a comprehensive range of services, including clinical trial activities and support, advanced imaging, radiotracer manufacturing, and leading imaging analysis services. We are committed to delivering high-quality imaging solutions and accelerating the development of life-saving treatments.

Key Responsibilities:

• Lead technology transfer activities for radiopharmaceutical processes, including transfer from R&D to GMP manufacturing and between sites.
• Develop and execute technology transfer plans, protocols, and reports in alignment with regulatory expectations.
• Oversee analysis method optimization, method validation, and process validation.
• Support the production and quality control of PET radiopharmaceuticals.
• Ensure compliance with GMP, FDA and other applicable regulatory requirements during transfer and manufacturing activities.
• Collaborate cross-functionally with process development, quality assurance, regulatory affairs, and program management.
• Troubleshoot and optimize radiochemical synthesis processes and analytical methods.
• Train receiving site personnel and ensure knowledge transfer and documentation completeness.
• Travel domestic and international collaboration sites to support on-site technology transfer, training, and process implementation.

Qualifications and Requirements:

• Ph.D. in Radiochemistry, Organic Chemistry, or a related field (Master’s degree with extensive experience may be considered).
• Minimum of 5 years of experience in Fluorie-18 radiopharmaceutical production or a related field.
• Demonstrated experience in technology transfer, process validation, or scale-up in a GMP environment.
• Strong knowledge of GMP and regulatory requirements for radiopharmaceuticals.
• Hands-on experience with automated synthesis modules and analytical techniques (HPLC, GC).
• Proven ability to troubleshoot and optimize complex radiochemical processes.
• Strong communication skills, especially in cross-site and cross-functional environments.
• Ability to work independently and manage multiple projects in a fast-paced environment.
• Willingness and ability to travel (estimated 20-40%, including international travel as needed).

Preferred but not required:

• Experience supporting IND/NDA submissions or regulatory inspections.
• Familiarity with clinical manufacturing and multi-site operations.

Unique Department Requirements:

• This role will require flexibility to support intensive, on-site activities during technology transfer phases.
• Ability to work effectively across multiple time zones and international teams.
• Comfort working in a fast-evolving environment, where processes, timelines and priorities may change.
• Willingness to engage in hands-on laboratory and manufacturing activities, including troubleshooting and on-the-floor support during critical operations.

PLEASE NOTE:

Please note that since this is position is at least partially onsite, in the case of epidemic or other health crisis, employee must be willing to take reasonable steps to ensure that bacterial and viral infections are not spread to others including but not limited to temperature checks, vaccinations, exclusion from the office building, and other precautions as required by the building’s landlord.

What We Offer:

• Competitive Salary
• Comprehensive Health Insurance Plan
• Long-Term Disability
• Life Insurance
• Retirement Plan

XingImaging, a Mitro Company provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability, genetic information, service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Equal employment opportunity applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfer, leave of absence, compensation, and training.