Quality Control Associate - 139933

In 2022, businessman and philanthropist T. Denny Sanford committed $150 million to the creation of the Sanford Stem Cell Institute at UC San Diego. This gift combines current infrastructure with new Centers intended to leverage the advantages of space-based science, including expansion and, in some ways, quite literally launch stem cell research and regenerative medicine at UC San Diego into new spaces, endeavors, and training of future stem cell scientists.

Sanford Stem Cell Institute provides essential physical and human resources needed to leverage stem cell research currently being conducted at UC San Diego. Due to the complexity of regenerative medicine projects and substantial institutional investment, daily Sanford Stem Cell Institute personnel work with all 9 Vice Chancellor areas: Academic Affairs; Research Affairs; Equality, Diversity, and Inclusion; Student Affairs; Marine Sciences; Health Sciences; Health System; Chief Financial Officer; Advancement; Resource Management and Planning.

As part of UC San Diego, Sanford Stem Cell Institute motivates University-wide change, sustainability, and partnership, focusing on creating the structure under which various innovative regenerative medicine units and initiatives are developed.

The new UC San Diego Sanford Stem Cell Institute builds upon a $100 million gift in 2013 from T. Denny Sanford that established UC San Diego as a leader in developing and delivering the therapeutic promise of human stem cells - special cells with the ability to develop into many different cell types and which, when modified and repurposed, have the potential to treat, remedy or cure a vast array of conditions and diseases.

The new UC San Diego Sanford Stem Cell Institute includes six (6) stem cell Centers led by Center Directors and Deputy Directors and one (1) Brain Tumor and Neuro-Restoration Program.

1.Sanford Integrated Space Stem Cell Orbital Research (ISSCOR) Center, for stem cell research that will be conducted in a laboratory bay located aboard the International Space Station currently in low-Earth orbit.

2.Sanford Stem Cell Fitness and Space Medicine Center, which conducts in-depth space fitness and orbital medicine that can benefit both astronauts and people living on Earth.

3.Sanford Stem Cell Innovation Center, which will support regenerative medicine company development, including contract research in low-Earth orbit.

4.Sanford Stem Cell Discovery Center, which conducts basic and translational stem cell research.

5.Sanford Advanced Therapy Center, which provides fundamental tools and services to move basic research findings to next stages, such as early phase trials.

6.Sanford Stem Cell Clinical Center, which conducts research to accelerate relevant drug and therapy development in regenerative medicine, including clinical trials.

The Advanced Cell Therapy Laboratory (ACTL), housed under the Sanford Advanced Therapy Center (SATC), offers expert assistance and hands-on services to investigators who require cGLP/cGMP systems and facilities. We aid in the transition from research and development to compliant and clinically-relevant manufacture of cell therapy products for IND-enabling studies or Phase I/II trials.We provide assistance with cell banking, process development and scale-up, product characterization, document writing, product stability assessment, and packaging.

Under supervision, the QC Associate will focus on QC activities supporting the manufacturing of cell therapy products. This includes release and stability testing of cell therapy products, maintaining the QC laboratory and instruments, authoring and revising standard operating procedures (SOPs) & certificates of analysis, and managing off-site testing of QC samples. Will perform environmental monitoring of the production suites as needed.

Works on research data reporting assignments that are of moderate diversity in scope. Exercises judgmentwithin generally defined practices and policies in selecting methods and techniques for obtaining solutions. Performs other duties as assigned.

• Six (6) years of related experience, education/training, OR a Bachelor's degree in related area (scientific discipline) plus two years of related experience/training.

• Working knowledge of research function. Knowledge of test methods used to test cell therapy products or similar characterization assays.

• Skills to communicate complex information in a clear and concise manner both verbally and in writing.

• Willingness to adhere to established UCSD guidelines for safety and environmental issues.

• Working skills in analysis and consultation. Strong analytical and critical thinking skills, with the ability to quickly analyze problems.

• Experience using basic laboratory equipment; knowledge of safe laboratory procedures.

• Working skills in statistical analysis, systems programming, database design and data security measures.

• Strong organizational skills with ability to prioritize tasks and to work under the pressure of multiple demands.

• Familiarity with the Miltenyi CliniMACs or similar flow cytometry devices, QPCR intruments, and absorbance readers.

• Hands-on experience in a pharmaceutical, biotech, drug manufacturing, or academic environment is required, with knowledge of clean room practices being essential.

• Strong skills using FlowLogic, MACSQuantify, FACS DIVA, or similar, as well as MS Word and Excel.

• Working knowledge of laboratory Good Manufacturing Practice (GMP), Food and Drug Administration (FDA), United States Pharmacopeial Convention (USP), and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Regulations.

• Environmental monitoring experience a plus.

• Employment is subject to a criminal background check.

• Willingness to work in Biosafety Level II environment where biological (including infectious agents and blood borne pathogens) hazards are present.

• Willingness to work with embryonic stem cells, work with viruses that are infectious to humans, including adeno-associated viruses, Sendai viruses, and lentiviral vectors which are derived from human immunodeficiency virus (HIV).

• Must be able to work various hours and locations based on business needs.