Senior Scientist, Radiochemistry Expert

5 days ago


New Haven, Connecticut, United States XingImaging, LLC Full time

Job Summary

XingImaging, LLC is seeking a highly qualified Senior Scientist, Radiochemistry to join our team. The ideal candidate will possess a Ph.D. in Chemistry and have a minimum of three years of experience in radiopharmaceutical manufacturing for human use.

Main Responsibilities:

  • Lead and oversee the development, synthesis, and production of radiopharmaceuticals for human use, ensuring compliance with GMP and GxP standards.
  • Collaborate with cross-functional teams to optimize manufacturing processes and improve product quality.
  • Conduct and interpret complex chemical analyses related to radiopharmaceuticals, ensuring the accuracy and reliability of results.
  • Maintain and ensure adherence to regulatory requirements, including documentation and reporting as per GxP guidelines.
  • Troubleshoot and resolve technical issues in the production process to ensure continuous improvement and operational efficiency.
  • Participate in the preparation and review of standard operating procedures (SOPs) and batch records related to radiopharmaceutical production.
  • Train and mentor junior chemists and technicians, fostering a culture of safety, quality, and continuous learning within the team.
  • Stay updated with the latest advancements in radiopharmaceuticals, GMP, and GxP regulations, and implement best practices in the laboratory and manufacturing settings.

Requirements:

  • Ph.D. in Organic Chemistry or Radiochemistry
  • Proven experience in radiochemistry, specifically with fluorine-18 (F 18) synthesis with a GMP manufacturing environment
  • Strong technical background in chemistry, excellent analytical problem-solving skills. Capable of independently developing and troubleshooting problems in a fast-paced environment
  • Availability and willingness to travel both domestically and internationally, up to 10% of time
  • Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national, and local regulations and laws related to clinical trials and clinical manufacturing. Knowledge of radiopharmaceutical regulation is a plus.
  • Excellent project management skills, independence, self-motivation, organizational skills, and attention to detail
  • Embodies ethics and integrity in all work, respecting both company and broader community policies in all conduct
  • Strong commitment to the team; maintains positive working relationships with diverse people, including internal team and external partners

Unique Department Requirements:

  • This position works in an environment with radiopharmaceuticals
  • May need to lift metal shielded storage containers weighing 65 pounds

What We Offer:

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


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