FAC MGT SPEC 2 CX

Job Description

Department Description:

Dr. Brian Shy 's Research Laboratory is dedicated to advancing the therapeutic application of genome and epigenome engineering tools for a wide range of indications, including cancer, rare diseases, infectious diseases, autoimmunity, and transplant-related conditions. The successful outcomes from the research are transferred to the Cellular Therapy Development (CTD) Laboratory, where cellular therapy manufacturing processes are developed before transfer over to the GMP facility.

Job Summary:

The Operations Specialist will be an integral member within the Operational Team, functioning under the guidance and supervision of the Operations Manager. They will play an active role in executing operational tasks within the UCSF Human Islet and Cellular Transplantation Facility (HICTF), a GMP facility dedicated to the manufacture of experimental cell therapies. In addition, they will support the daily maintenance of process development lab and support requests from Dr. Shy's research lab, while ensuring compliance with UCSF policies, regulations, and safety standards.

he Operations Specialist will serve as a point of contact for the labs and support key administrative functions, including coordinating laboratory schedules to ensure smooth and efficient operations. They will also assist with maintaining and scheduling equipment maintenance and repairs, and help facilitate clear communication and collaboration between research groups, core facilities, vendors, and lab teams.

The Operations Specialist will play a vital role by supporting the work of cellular therapy process development and manufacturing teams. Key duties include assisting with the establishment and upkeep of Standard Operating Procedures (SOPs) for equipment, techniques, and safety protocols; processing order requests, overseeing the receipt, shipping, and handling of inventory, which includes materials, chemicals, gases, and equipment. They will also assist with restocking supplies, maintaining a clean and organized laboratory environment; supporting the monitoring and response to alarms and out-of-specification conditions related to equipment and laboratory environmental conditions. Additionally, they will assist with SOP and EH&S compliance, including investigations, audits, corrective actions, and process improvements. Support deviations, change controls, and compliance documentation..

Responsibilities

• Manage and oversee operational activities for Dr. Brian Shy's Research Laboratory and the Cellular Therapy Development Laboratory.
• Coordinate and plan facility-related moves, ensuring smooth transitions and minimal disruptions.
• Develop and implement procedures, policies, and communications related to infrastructure and safety, in line with laboratory protocols.
• Triage and track repair services, ensuring timely maintenance and repairs for specialized facility systems.
• Conduct space planning and general maintenance, optimizing the use of laboratory space and resources.
• Collaborate with the research team to understand their needs and requirements, providing effective solutions and support.
• Ensure compliance with safety regulations and guidelines, promoting a culture of safety within the laboratories.
• Maintain open lines of communication with laboratory staff, addressing their concerns and providing regular updates.
• Monitor and analyze facility performance, identifying areas for improvement and implementing necessary changes.
• Stay updated with the latest advancements in facility management and laboratory operations, attending relevant training and workshops.

Qualifications

Required Qualifications:

• Associate degree in Science, Technology, Engineering, Nursing or Math-related field and/or at least 2 years of experience research lab or drug manufacturing lab operations or an equivalent combination of education and experience
• Knowledge in basic laboratory procedures and skills (documentation, reagent handling, equipment troubleshooting)
• Good interpersonal and communication skills
• Able to multi-task and prioritize activities effectively
• Able to work independently and as part of a team

Preferred Qualifications:

• Experience in research lab or drug manufacturing lab operations
• Knowledge of aseptic techniques