UC San Diego Looking for Senior Manufacturing Associate – 123228 at Oakland, CA  Full Time

For the safety and well-being of the entire university community, the University of California requires, with few exceptions, that all students, faculty and staff be vaccinated against the COVID-19 virus and influenza before they will be allowed on campus or in a facility or office. For more information visit: /

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 scale-up, product characterization, document writing, product stability assessment, and packaging.

Under minimal supervision, incumbent is responsible for performing GMP (Good Manufacturing Practice) cell culture and the associated assays within a laboratory or clean room and will participate in complex projects that may require original contribution. Responsibilities include conducting and occasionally leading cell therapy product manufacturing activities; planning and executing work tasks. Incumbent will perform a broad range of laboratory activities in the support of cell therapy products under cGMP for use in pre-clinical & clinical studies, including the manufacture, testing and storage of GMP products. Will contribute to the evaluation and purchasing recommendations of laboratory equipment.

Incumbent will undertake translational research and development and support validation studies of processes and equipment as required. Will perform and as appropriate lead all associated ACTL procedures that are required to ensure the daily operation of the ACTL and to maintain ACTL licensing and accreditation, as indicated. Responsible for participating in the quality management and accreditation process. Responsible for culturing T cells, NK cells, neuronal cells, stem cells human pluripotent stem cells, and other cell types derived from donors. Will train others on culturing and assay techniques.

MINIMUM QUALIFICATIONS

• Bachelor’s degree in a science related field of study plus three (3) years of experience in the kind of work to be performed; or a combination of education and experience; and knowledge and abilities essential to the successful performance of duties assigned to the position.

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

• Strong understanding of cGMP and cGLP guidelines as well as knowledge of The United States Food and Drug Administration (FDA) guidelines and regulations.

• Demonstrated experience making independent decisions, analyzing situations and problem solving. Proven ability to work independently and function in a team.

• Advanced experience and analysis with aseptic cell culture methods, including cryopreserving, thawing, and expanding cell lines, is required.

• Experience with protocol development, testing, analyses and validation and with developing related Standard Operating Procedures (SOP). Ability to follow detailed instructions described in SOP and Batch Production Records and to record data accurately and in a legible manner per GMP requirements.

• Demonstrated experience with the Miltenyi MacsQuant or similar flow cytometry device, qPCR instruments, absorbance readers and other cell characterization equipment.

• Willingness to work in environment where biological (including infectious agents and blood borne pathogens), chemical, and radiological hazards are present, to perform research on the human pluripotent stem cell, to 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).

• Strong computer skills including knowledge of PC software applications such as Word and Excel to produce manuscripts, reports, correspondence, graphs, and spreadsheets to generate, track, and analyze required data. Demonstrated ability to navigate and utilize electronic mail systems and the internet.

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 human pluripotentstem 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 including occasional weekends.

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 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:

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

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