Staff Radiochemist, Cyclotron and Radiochemistry Facility

🔍 School of Medicine, Stanford, California, United States

📁: Research

📅   : Apr 18, 2024 Post Date

📅   : 98009 Requisition #

Stanford University is seeking a Research and Development Scientist and Engineer 1 to provide highly specialized technical research and support, expert instruction, and consultation involved directly in the development and execution of Cyclotron Radiochemistry Facility (CRF) production and research activities. The candidate will work under the direction of a CRF Manager with respect to the department’s radiochemistry program needs, including advanced and novel radiotracer production, troubleshooting, and prioritization/facilitation of clinical translation.

Duties include:

Develop and implement protocols for manufacturing both novel and known radiopharmaceuticals for clinical and/or preclinical research purposes.
Conduct advanced 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 and develop laboratory equipment (including cyclotron, radiosynthesis modules, HPLC, GC) using mechanical, electrical, and chemistry 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 both 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 use, radiation safety, SOPs, HIPAA, and others as required.

* - Other duties may also be assigned.

DESIRED QUALIFICATIONS:

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 radiolabeling strategies and troubleshooting.
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).
Extensive experience with radiotracer quality control techniques, including High Performance Liquid Chromatography (HPLC), Thin Layer Chromatography (TLC), gas chromatography (GC), Radioactivity Detectors, endotoxin, etc.
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> Radiopharmaceutical Drug Production.
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.
Ability to work independently and/or as part of a cross-functional team.

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree and three years of relevant experience, or combination of education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

Thorough knowledge of the principles of engineering and related natural sciences.
Demonstrated project management experience.

PHYSICAL REQUIREMENTS*:

Frequently grasp lightly/fine manipulation, perform desk-based computer tasks, lift/carry/push/pull objects that weigh up to 10 pounds.
Occasionally stand/walk, sit, twist/bend/stoop/squat, grasp forcefully.
Rarely kneel/crawl, climb (ladders, scaffolds, or other), reach/work above shoulders, use a telephone, writing by hand, sort/file paperwork or parts, operate foot and/or hand controls, lift/carry/push/pull objects that weigh >40 pounds.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS:

May be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA, Allergens/Biohazards/Chemicals /Asbestos, confined spaces, unusual work hours and occasional overtime.

WORK STANDARDS:

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.

The expected pay range for this position is $108,000 to $139,000 per annum.
Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

As an organization that receives federal funding, Stanford University has a COVID-19 vaccination requirement that will apply to all university employees, including those working remotely in the United States and applicable subcontractors. To learn more about COVID policies and guidelines for Stanford University Staff, please visit https://cardinalatwork.stanford.edu/working-stanford/covid-19/interim-policies/covid-19-surveillance-testing-policy

Additional Information