Details
Posted: 15-Feb-22
Location: La Jolla, California
Salary: Open
UCSD Layoff from Career Appointment: Apply by 02/07/2022 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 02/17/2022. Eligible Special Selection clients should contact their Disability Counselor for assistance.
DESCRIPTION
The Department of Medicine is the largest department within the UCSD School of Medicine and is responsible for fulfilling the teaching, research, and clinical missions of the University of California, San Diego School of Medicine. The department employs approximately 500 salaried faculty, 168 academic appointees, 331 residents, fellow and postdocs and 479 staff personnel.The Advanced Cell Therapy lab is a state-of-the-art cGMP manufacturing facility whose highly skilled team will support UC and local investigators transition novel therapies through the IND and Phase I/II clinical trials.
The Quality Control 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.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.
MINIMUM QUALIFICATIONS
Bachelor's Degree in related area (scientific discipline) plus a minimum of two (2+) or more years of quality control experience OR six (6) years of quality control experience.
Working knowledge of research function. Experience in test methods used to test cell therapy products or similar characterization assays.
Strong skills to communicate complex information in a clear and concise manner both verbally and in writing.
Proven skills in analysis and consultation. Strong analytical and critical thinking skills, with the ability to quickly analyze problems.
Demonstrated experience using basic laboratory equipment; knowledge of safe laboratory procedures.
Advanced working skills in statistical analysis, systems programming, database design and data security measures.
PREFERRED QUALIFICATIONS
- Familiarity with the Miltenyi CliniMACs or similar flow cytometry devices, QPCR instruments, 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.
SPECIAL CONDITIONS
- 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.
