#123217 Quality Control Associate

DESCRIPTION

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.

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.

MINIMUM QUALIFICATIONS

• Willingness to adhere to established UCSD guidelines for safety and environmental issues.
• Working skills in statistical analysis, systems programming, database design and data security measures.
• Experience using basic laboratory equipment; knowledge of safe laboratory procedures.
• Working knowledge of research function. Knowledge of test methods used to test cell therapy products or similar characterization assays.
• Six (6) years of relevant experience or a Bachelor's degree in a related field plus two (2) years of related/relevant experience.
• Working skills in analysis and consultation. Strong analytical and critical thinking skills, with the ability to quickly analyze problems.
• Skills to communicate complex information in a clear and concise manner both verbally and in writing.

PREFERRED QUALIFICATIONS

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

SPECIAL CONDITIONS

• Willingness to work in Biosafety Level II environment where biological (including infectious agents and blood borne pathogens) hazards are present.
• Must be able to work various hours and locations based on business needs.
• 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).

Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).
If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.

UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!

Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.

To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit UC San Diego Principles of Community.

UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html

UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.

UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening.