The Diabetes Center is seeking a Specialist to serve as lead oversight for a cutting edge clinical cell therapy program. The Specialist will serve as the lead manufacturer during the clinical manufacturing process for regulatory T cell based cell therapies in preparation for first-in-human clinical trials in a cGMP cellular therapy manufacturing facility at UCSF. The Specialist will have direct supervision of the members of the clinical manufacturing team, and will also work closely with the clinical team, QA team, regulatory team, and microbiology to ensure that cell products are manufactured and prepared for release and infusion under GMP-compliant conditions. The Specialist will be responsible for ensuring the manufacturing team is fully trained and proficient on standard operating procedures (SOPs) related to clinical manufacturing. The Specialist will also oversee and schedule the daily activities of the manufacturing team, which will include assigning research experiments, data analysis, and lab maintenance tasks to individuals on the team.
In conjunction with the QA and regulatory teams, the Specialist will write and review SOPs, training checklists, qualification plans, study reports, and other as needed FDA-related documentation. The Specialist will be responsible for ensuring that all records for clinical manufacturing are maintained according to FDA guidelines, and that all post-release assays are completed and fully documented. The Specialist will also be involved in qualification and maintenance of equipment and reagents to be used in the GMP facility, including scheduling vendors and the completion of appropriate documentation, ensuring compliance with GMP guidelines.
As new technology becomes available, the Specialist will assist in developing and evaluating new procedures and protocols, including experimental design and execution, to be used in current and future clinical trials. The Specialist will ensure that all new procedures and protocols transferred for use in clinical manufacturing are properly implemented following FDA guidelines, including documentation in the form of qualification plans, study reports, and standard operating procedures. The Specialist will also ensure that all appropriate personnel are trained and documented on the new procedures to demonstrate proficiency in compliance with GMP guidelines.
Required Qualifications: • Appointees to the Associate rank should possess a master’s degree (or equivalent degree) in immunology or a related field or five to ten years of experience demonstrating expertise in the relevant specialization. • Appointees to the Full Specialist rank should possess a terminal degree (or equivalent degree) in immunology or a related field or ten or more years of experience demonstrating expertise in the relevant specialization. • 5+ years of expertise in an immunology laboratory • 5+ years of expertise in a Good Manufacturing Practices (GMP) facility • 5+ years of expertise in GMP documentation • Understanding of basic GMP requirements in drug manufacturing • Expertise with blood processing • Expertise with T cell isolation and manipulation • Expertise with cellular therapy or biologic drug development • Expertise with aseptic technique with respect to cell culture • Adept in Microsoft Office • Excellent verbal/written communication • Flexibility in the face of changing priorities and schedules • Organizational skills, time management, administrative, and data recording skills • Ability to prioritize tasks, multi-task, and coordinate work tasks with others and meet multiple deadlines
Preferred Qualifications: • Working knowledge of SunQuest/APEX • Working knowledge of RedCap • Working knowledge of OnCore
Appointees in the Specialist series will be expected to engage in specialized research, professional activities and do not have teaching responsibilities. Specialists are expected to use their professional expertise to make scientific and scholarly contributions, and may participate in University and Public Service.
Screening of applicants will begin immediately and will continue as needed throughout the recruitment period. Salary and rank will be commensurate with the applicants experience and training.
UC San Francisco seeks candidates whose experience, teaching, research, or community service that has prepared them to contribute to our commitment to diversity and excellence. The University of California 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, disability, age or protected veteran status.
Internal Number: JPF02464
About University of California, San Francisco
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 high-quality patient care. It is the only UC campus in the 10-campus system dedicated exclusively to the health sciences.