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Sr Radiochemist
MISSION STATEMENT
The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.
SUMMARY
The primary purpose of the Senior Radiochemist position is the responsibility for the safe manufacturing and quality control of radiopharmaceuticals for Positron Emission Tomography (PET) under Good Manufacturing Practice (GMP) to be used for clinical and preclinical research protocols. Work practices must be in compliance with regulatory requirements. The Senior Radiochemist will also provide guidance and supervision to other radiochemists and personnel involved in the manufacturing and quality control process.
JOB SPECIFIC COMPETENCIES
Manufacturing Operations • The most important function is the production of Radiopharmaceuticals that are safe and are of the highest quality for use in clinical patients. This requires the operation, maintenance and calibration of automated and semi-automated radiopharmaceutical manufacturing and quality control equipment.
• Performs all duties associated with manufacturing and quality control of diagnostic imaging agents for PET.
• Contributes technical assistance and problem solving skills toward production problems that may arise.
• Provides guidance and supervision to other radiochemists and quality control personnel in the facility.
• In collaboration with staff, provides data and documentation to support Chemical Manufacturing and Control (CMC) documents as part of IND (Investigational New Drug) submissions to the FDA (Food and Drug Administration).
Quality Control Operations
• Performs quality control procedures in accord with established Standard Operating Procedures (SOPs), including analytical techniques such as radio-HPLC, GC, TLC, etc.
• Works independently, or cooperatively, to validate and implement analytical methods as required.
• Provides trouble shooting of analytical methods.
• Performs data interpretation and maintenance of analytical results, including back-up record keeping.
• Reports malfunctions and/or repair minor problems as possible.
• Maintains service and calibration records.
Research and Development • Works independently to develop and optimize radiolabeling procedures and analytical methods as tasked by the Lab Manager or Director.
• Contributes to the planning and development of new radiopharmaceuticals and analytical procedures.
• Provides suggestions and critical inputs on new ideas and approaches with Lab Manager or Director.
Regulatory Responsibilities • Follows Standard Operating Procedures (SOPs) to comply with Current Good Manufacturing Practice (cGMP) for manufacturing of PET radiopharmaceuticals and maintain compliance with regulatory requirements.
Reviews, evaluates and contributes to the development of SOPs.
• Ensures that data is recorded and accessible for review by Lab Manager or Director.
• Follows and observes all radiation safety procedures in agreement with the ALARA principle.
• Provides related training to other staff members when required.
Other duties as assigned
REQUIREMENTS
Education Required: Bachelor’s degree in Chemistry, Biochemistry or related field.
Preferred Education: Master’s or PhD Level Degree
Certification Required: None
Preferred Certification: None
Experience Required: Five years experience in manufacturing and or quality control of PET radiopharmaceuticals.
Preferred Experience: One year experience in research and development of PET radiopharmaceuticals
Onsite Presence: Is Required
This position may be responsible for maintaining the security and integrity of critical infrastructure, as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
