Senior Scientist, Radiochemistry

1 month ago

New Haven, United States XingImaging, LLC Full time

Position Overview

This is a regular, onsite full-time position in Connecticut.


We are seeking a highly qualified and experienced Senior Scientist, Radiochemistry with a strong background in radiopharmaceuticals to join our dynamic 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. This role requires a deep understanding of Good Manufacturing Practices (GMP) and GxP regulations, ensuring the highest quality and safety standards in the production of radiopharmaceuticals.


MAJOR AREAS OF RESPONSIBILITY:

  • 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.
  • Other responsibilities may be assigned as required by the business

 

QUALIFICATIONS AND REQUIREMENTS:

Required:

  • 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

 

 

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

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