Washington, DC
Iowa City, Iowa
La Jolla, California
Bronx, New York
Indianapolis, Indiana,
Saint Louis, Missouri
Posted: 05-Jan-23
Location: La Jolla, California
Salary: Open
Internal Number: 120834
UCSD Layoff from Career Appointment: Apply by 01/06/2023 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 1/18/2023. Eligible Special Selection clients should contact their Disability Counselor for assistance.
Placement within the salary range is determined by internal equity, relevant qualifications, and collective bargaining agreements (when applicable).
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 judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
MINIMUM QUALIFICATIONS
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.
PREFERRED QUALIFICATIONS
- 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.
SPECIAL CONDITIONS
- 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.
Pay Transparency Act Full Salary Range: $53,600 - $111,600 Annually
The University of California, San Diego is required to provide a reasonable estimate of the compensation range for this role. This range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be offered a salary at or near the top of the range for a position. Salary offers are determined based on final candidate qualifications and experience. The full salary range for this position is defined as the Full Pay Range. The budgeted salary or hourly range that the University reasonably expects to pay for this position defined as the Expected Pay Scale. Placement within the Expected Pay Scale is determined by internal equity, relevant qualifications, and collective bargaining agreements (when applicable).
