The Advanced Cell Therapy Laboratory (ACTL) 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.

Incumbent 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 facility monthly and to support product fills as needed.

Works on research data reporting assignments that are of moderate diversity in scope. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

• 6 years of related experience, education/training, OR a Bachelor's degree in related area (scientific discipline)plus 2 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.

• 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.