CLIN ENGR 3 at University of California, San Francisco (UCSF)

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

• 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 $87,900 - $187,700 (Annual Rate).
 

To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html

• 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.

• 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.