Physical Science Research Scientist
Physical Science Research Scientist🔍School of Medicine, Stanford, California, United States📁Research📅Apr 07, 2021 Post Date📅89096 Requisition #The Research Scientist will be involved directly with the development and execution of clinical and preclinical research goals/activities of the Cyclotron Radiochemistry Facility (CRF). The candidate will work under the direction of the facility manager with respect to the department’s radiochemistry program needs, including routine and novel radiotracer development, production, troubleshooting, and prioritization/facilitation of clinical radiotracer translation.Duties include:
- Develop and implement protocols for manufacturing both novel and known radiopharmaceuticals for clinical and/or preclinical research purposes.Conduct routine production of radiopharmaceuticals for clinical use according to cGMP standards.Perform Quality Control (QC) tests according to SOPs for radiopharmaceuticals (e.g., HPLC, TLC, GC, sterility, bioburden). Maintain accurate radiopharmaceutical production records (including master batch records and QC results).Operate the cyclotron and associated equipment in compliance with protocols and good ALARA radiation safety practices.Operate automated radiochemistry synthesis equipment in compliance with protocols and current Good Manufacturing Practices (cGMP) and FDA regulations.Troubleshoot laboratory equipment (including cyclotron, radiosynthesis modules, HPLC, GC) using mechanical, electrical, and basic engineering skills.Supervise/train junior staff radiochemists/postdocs on all activities involved in developing and preparing PET radiopharmaceuticals for clinical and research use. Write clear Standard Operating Protocols (SOPs) for QC protocols. Review existing SOPs and suggest logical modifications based on either scientific rationales and regulatory requirements.Independently prepare regulatory documents (i.e., chemistry manufacturing and controls, CMC) for submission to the FDA.Complete and maintain periodic training for GMP, equipment uses, radiation safety, SOPs, HIPAA, and others as required.
- Ph.D. degree or equivalent in radiochemistry or a related scientific field (e.g., chemistry) in addition to three years of relevant experience.Comprehensive understanding of radiochemistry with a focus on 18F/11C or radiometal radiolabeling strategies and troubleshooting.Extensive experience with radiotracer quality control techniques, including High Performance Liquid Chromatography (HPLC), Thin Layer Chromatography (TLC), gas chromatography (GC), Radioactivity Detectors, endotoxin, etc.Ability to follow established radiation safety procedures while developing and executing an approved radiochemistry production.General computer skills, experience with databases, cloud-based storage, and the ability to quickly learn/master various scientific computer programs (such as Chemstation, Tracerlab, Chromeleon etc.).Ability to work independently and/or as part of a cross-functional team.
- Expert level knowledge and hands on experience with operating, optimizing, and troubleshooting automated radiosynthesis platforms (prefer GE FX N and/or FX C series of automated modules).Prior experience with cyclotron operation is preferred.Familiar with CMC documentation for novel radiotracers, consistent with requirements for IND, NDA, ANDA, RDRC or other regulatory pathways.Prior experience with USP <823> or <825> Radiopharmaceutical Drug Production.
- Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.
- Schedule: Full-time
- Job Code: 6280
- Employee Status: Regular
- Grade: R99
- Department URL: http://radiology.stanford.edu/
- Requisition ID: 89096