Cell Therapy Operations Manufacturing

Employer
University of California, San Francisco
Location
Mission Bay (SF), Parnassus Heights (SF)

View more

Employment Type
Full Time
Institution Type
Four-Year Institution
Job Code and Payroll Title
005195 FAC MGT SPEC 3
Job Summary
 Uses (GMP) Good Manufacturing Practices  as a seasoned, experienced professional and implements and coordinates building management procedures and space planning activities. Develops space allocation project scope, schedule and budget plans for management review, implements and makes recommendations for new and revised procedures. Oversees various facilities-related operational activities. Has general knowledge about several operational functions. Receives little instruction on daily work, general instructions on new assignments. May function as a lead and resource or supervise support staff (for less than 2.0 FTE).
The Operations Coordinator will independently manage and perform critical cleanroom facility operational tasks that support cell therapy manufacturing programs. The Operations coordinator oversees all operations in the UCSF Human Islet and Cellular Transplantation Facility (HICTF) which is a GMP facility dedicated to the manufacture of experimental cell therapy. This position also serves as a bridge between the HICTF and the Cellular Therapy Development Laboratory (CTD lab) where process development activities take place.

The range of tasks include but are not limited to ensuring compliance with operational SOPs, handling inventory, receipt, and storage of equipment, supplies and materials, coordination and assist with internal audits and responses to external audits, assistance with error management, assist with training of new staff in cGMP processes, coordination of preventative maintenance of the CTD lab and HICTF and GMP Facility, coordination and performing cleanroom facility environmental monitoring, overseeing CTD and HICTF lab equipment QC and maintenance, overseeing emergency repairs of lab facilities and equipment, and coordinate and performing cleaning of the GMP cleanroom facility.

The Operations coordinator works closely with the head of QA to ensure that operations are in full compliance with applicable regulations and SOPs.

The Operations Coordinator will work with contractors and external clients to direct improvements to HICTF to prepare for manufacturing campaigns by external clients. This role requires close coordination between external client operations and QA staff, MCB building engineers, relevant contractors, and UCSF QA. Ongoing activities include ensuring that external clients have all their operational needs met by overseeing materials management, environmental monitoring, and room changeovers, in coordination with appropriate QA personnel.

The UCSF Cellular Therapy Development Laboratory is a dedicated laboratory where cellular therapy manufacturing processes are developed before transfer over to the GMP facility. The UCSF HICTF and GMP Facility is a multi-use cGMP cellular therapy manufacturing facility that manufactures several cell types for clinical trials across the country.



The Operations Coordinator will independently manage and perform critical cleanroom facility operational tasks that support cell therapy manufacturing programs. The Operations coordinator oversees all operations in the UCSF Human Islet and Cellular Transplantation Facility (HICTF) which is a GMP facility dedicated to the manufacture of experimental cell therapy. This position also serves as a bridge between the HICTF and the Cellular Therapy Development Laboratory (CTD lab) where process development activities take place.

The range of tasks include but are not limited to ensuring compliance with operational SOPs, handling inventory, receipt, and storage of equipment, supplies and materials, coordination and assist with internal audits and responses to external audits, assistance with error management, assist with training of new staff in cGMP processes, coordination of preventative maintenance of the CTD lab and HICTF and GMP Facility, coordination and performing cleanroom facility environmental monitoring, overseeing CTD and HICTF lab equipment QC and maintenance, overseeing emergency repairs of lab facilities and equipment, and coordinate and performing cleaning of the GMP cleanroom facility.

The Operations coordinator works closely with the head of QA to ensure that operations are in full compliance with applicable regulations and SOPs.

The Operations Coordinator will work with contractors and external clients to direct improvements to HICTF to prepare for manufacturing campaigns by external clients. This role requires close coordination between external client operations and QA staff, MCB building engineers, relevant contractors, and UCSF QA. Ongoing activities include ensuring that external clients have all their operational needs met by overseeing materials management, environmental monitoring, and room changeovers, in coordination with appropriate QA personnel.

The UCSF Cellular Therapy Development Laboratory is a dedicated laboratory where cellular therapy manufacturing processes are developed before transfer over to the GMP facility. The UCSF HICTF and GMP Facility is a multi-use cGMP cellular therapy manufacturing facility that manufactures several cell types for clinical trials across the country.



 
Organization
Campus
Req Number
66209BR
Job Title
Cell Therapy Operations Manufacturing
Employee Class
Career
Percentage
100%
Shift Length
8 Hours
Shift
Days
Additional Shift Details
M-F 8-5 and occasional nights and weekends
Bargaining Unit
99 - Policy-Covered (No Bargaining Unit)
Job Category
Professional (Non-Clinical)
Required Qualifications
  • Bachelor's degree in Science, Technology, Engineering, or Math-related field and/or an equivalent combination of education and experience
  • 5 years of experience in research lab or drug manufacturing lab operations
  • Proficiency in basic laboratory procedures and skills (documentation, reagent handling, equipment troubleshooting)
  • Strong interpersonal and communication skills.
  • Thorough interpersonal skills including good service orientation and effective problem solving.
  • Knowledge of architectural or engineering concepts.
  • Thorough and effective skills to multi-task and prioritize daily activities effectively.

Preferred Qualifications
..
Position Type
Full Time
Department Name
Laboratory Medicine
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 UC San Francisco Diabetes Center is a comprehensive research and treatment facility with a broad focus on clinical care, education and both basic and clinical research. The Center maintains a multidisciplinary and highly collaborative environment that brings together expertise from the UCSF Departments of Medicine, Surgery, Pediatrics, Microbiology & Immunology, and others. The Diabetes Center encompasses both the Islet Transplant Center and the Immune Tolerance Network. The UCSF Islet Transplant Center is a traditional clinical research facility dedicated to the advancement of treating diabetes through islet transplantation. The Immune Tolerance Network (ITN) is a National Institutes of Health-funded initiative to facilitate the advancement of immune tolerance-inducing procedures in human clinical practice, towards the development of new and improved treatment and monitoring protocols in kidney and islet transplantation, autoimmune disease, and asthma & allergic diseases.  With approximately $13 million dollars in funding per year, the Network is responsible for all aspects of the implementation of the mechanistic, laboratory-based studies and the clinical trials. The structure of the Diabetes Center will resemble that of a matrix organization, with the Diabetes Center, the ITN and the Islet Center all being self-contained cells functioning autonomously but at the same time working towards a unified goal.
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

Join us to find a rewarding career contributing to improving healthcare worldwide.
Location
Mission Bay (SF), Parnassus Heights (SF)

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert