Radiochemist

Job Summary The Radiochemist applies extensive knowledge of radiochemistry in the manufacturing of clinical-grade radiopharmaceuticals to ensure quality of clinical and investigational radiopharmaceuticals as specified by the standards stated in 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 areas across the medical center and health system.

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

The radiochemist develops 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

)

Required Qualifications

Bachelor's degree in radiochemistry, chemistry or related area and/or equivalent experience/training

Minimum of three years of related experience

Demonstrated ability of working with Word and Excel and experience with designing complex spreadsheets and produce clear reports

Ability to resolve problems and exercise sound judgment in ambiguous environments

Ability to manage multiple tasks, manage time well, and set/adjust priorities in a dynamic, fast-paced, deadline-oriented work environment

Ability to work collaboratively with faculty and staff at all levels of the organization, maintain a positive, problem-solving approach, and demonstrate a high degree of professionalism

Demonstrated initiative, problem solving skills and analytical organization, communication and interpersonal skills

Fosters collaboration throughout the organization. Ability to identify expectations and ensures they are met through regular communications and excellent service

Ability to manage a project through to completion while performing a wide variety of tasks, adapting to changing priorities, deadlines and directions

Interpersonal skills to maintain professional relationships with a diverse team of engineers, technicians, chemists, faculty, and administrative staff

Skills to evaluate issues and identify solutions within defined procedures and policies. Demonstrated ability to address problems and suggest solutions through critical thinking process

Verbal and written communication skills to explain technical Clinical Engineering concepts and articulate reasoning behind own opinions. Demonstrates active listening skills to understand varying opinions and receive feedback

Preferred Qualifications

MS in radiochemistry, chemistry, or a related field

PhD in radiochemistry, chemistry, or related field

Good working knowledge of the UC systems, academic and staff personnel policies

Experience in development of radiopharmaceuticals, preferably in radiometal synthesis

Experience working in a radiopharmaceutical production facility

Proven knowledge of policies and procedures related to FDA, state agencies, and other regulatory authorities

Technical skills to maintain and repair radiopharmaceutical synthesis modules and quality control equipment

Thorough knowledge of cGMP and FDA regulations related manufacturing radiopharmaceuticals

Strong knowledge of radiopharmaceutical synthesis modules and quality control equipment. Understand the architecture of how systems / applications function and interact with others

About UCSF The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world's leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.

Pride Values UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence - also known as our PRIDE values.

In addition to our PRIDE values, UCSF is committed to equity - both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at diversity.ucsf.edu

Equal Employment Opportunity The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.

Organization Campus: China Basin (SF)

Location: San Francisco, CA

Work Style: Fully On-Site

Shift: Days (8 Hours, M-F 8 AM-5 PM variable time)

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