Radiochemist University of California San Francisco

The Radiochemist applies extensive knowledge of radiochemistry in the manufacturing of clinical-grade radiopharmaceuticals to ensure the quality of clinical and investigational radiopharmaceuticals as specified by the standards stated in the USP Chapter and 21 CFR 212. Investigates incidents, with a focus on specific technologies. Performs equipment installation, maintenance, repair and technical support projects autonomously from start to completion in functional area across the medical center and / or health system.

The candidate will report to the Assistant Director of the Radiopharmaceutical Facility (RPF) in the development of standard operating procedures for the investigational Positron Emission Tomography (PET) drugs such that the facilities, equipment, and inventory control meet the associated regulatory requirements.

The radiochemist will develop new approaches in the synthesis and labeling of novel radiopharmaceuticals for clinical use, and works with a multidisciplinary team in developing Chemistry, Manufacturing, and Control for investigational drug applications (IND) and New Drug Applications/Abbreviated New Drug Application (NDA/ANDA) submitted to the FDA.

Key responsibilities:

• Lead the development of new procedures for the translation of new and/or novel radiotracers for investigational clinical use.
  • Develop manual or automated radiosynthesis protocols for manufacturing clinical-grade radiopharmaceuticals
  • Develop quality control methods for new or novel radiopharmaceuticals
• Plan and perform production and quality control of radiopharmaceuticals according to current good manufacturing practices and aseptic technique

• Ensure that all manufacturing equipment are suitable and in working condition and all raw materials are qualified and within expiry before radiopharmaceutical production
• Ensure that radiopharmaceuticals used for clinical and research applications pass all associated QC tests prior to release.

* Perform root cause analysis and initiate investigations following any out-of-specification or deviation from radiopharmaceutical manufacturing procedure

• • Perform updates and changes to SOPs through change control (CC) and corrective and preventive actions (CAPA)

* Design and perform method validations, installation qualifications, and preventative maintenance on related chemistry equipment
* Follow UCSF radiation and laboratory safety policies

• Prepare Chemistry, Manufacturing, and Controls (CMC) section for investigation of new drug (IND), New Drug Applications (NDA/ANDA)

• Develop Standard Operating Procedures (SOP) for manufacturing of clinical radiopharmaceutical
• Perform Qualification and Validation runs for developed procedures
• Prepare responses for FDA Information Request (IR) related to the CMC section
  • Update CMC for changes in SOPs

• Follow and keep abreast with standards, regulations, and guidelines related to radiopharmaceutical manufacturing (21CFR 212 and USP )

The final salary and offer components are subject to additional approvals based on UC policy.

Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.

The salary range for this position is $87,900 - $187,700 (Annual Rate).

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