Clin Engr 3

Job Description
The Radiochemist applies extensive knowledge of radiochemistry in the manufacturing of clinicalgrade radiopharmaceuticals to ensure the quality of clinical and investigational radiopharmaceuticals as specified by the standards stated in the USP Chapter <823> 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) 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 clinicalgrade 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 outofspecification 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 <823>

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 $87900 $187700 (Annual Rate).

To learn more about the benefits of working at UCSF including total compensation please visit: 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 fastpaced deadlineoriented work environment

Ability to work collaboratively with faculty and staff at all levels of the organization maintain a positive problemsolving 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.

• 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.

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.

Department Description
The Department of Radiology & Biomedical Imaging is one of the largest departments in the School of Medicine at UCSF. Its mission is research (basic and clinical) teaching patient care and public service. The Department has 32 sections and research units 132 fulltime faculty 45 other academic (research) appointees 34 fellows 51 residents 40 post docs and 16 graduate students across six sites: Parnassus SFGH VA Medical Center Mt. Zion China Basin Landing and Mission Bay (QB3. Many faculty conduct research activities and manage large research staff including students fellows post docs and staff research associates. Some conduct bench research in wet lab settings; others have dry lab (computer based) research programs or specialize in clinical research. The Cyclotron Facility is a specialized particle production service that allows clinicians and investigators to have access to locally produced radiopharmaceuticals.

About UCSF
The University of California San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research graduatelevel education in the life sciences and health professions and excellence in patient care. It is the only campus in the 10campus UC system dedicated exclusively to the health sciences. We bring together the worlds 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

Join us to find a rewarding career contributing to improving healthcare worldwide.