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Quality Control Specialist

2 months ago

Dallas, Texas, United States UT Southwestern Medical Center Full time
Job Summary

The Department of Radiology at UT Southwestern Medical Center is seeking a highly skilled Senior Research Associate to join Dr. Sun (Xiankai) Lab as a Quality-Control Radiochemistry Specialist. This role is crucial to the quality delivery of investigational radiopharmaceuticals for clinical practice and research at UT Southwestern, ensuring compliance with FDA regulations.

Key Responsibilities
  • Perform quality-control assays, including troubleshooting, for investigational radiopharmaceuticals manufactured by the cyclotron facility.
  • Maintain QC lab instruments and records of CRP's material supplies according to FDA's Guidance for PET Drugs - Current Good Manufacturing Practice (CGMP).
  • Develop new QC SOPs for investigational new drug (IND) applications.
  • Participate in the design and development and evaluation of novel radiotracers.
  • Work as a backup to CRP's Regulatory Affairs Officer Associate.
Requirements
  • Ph.D. degree with major coursework in the field of assignment and no experience required.
  • Master's degree with major coursework in the field of assignment and five (5) years laboratory experience, including at least two (2) years at the level of Research Associate or equivalent.
  • Bachelor's degree with major coursework in the field of assignment and six (6) years laboratory experience, including at least two (2) years at the level of Research Associate or equivalent.
What We Offer

UT Southwestern Medical Center is committed to providing a comprehensive benefits package to eligible employees, including a PPO medical plan, paid time off, retirement programs, paid parental leave benefit, wellness programs, tuition reimbursement, and public service loan forgiveness (PSLF) qualified employer status.