QUALITY CONTROL LEAD SCIENTIST
Company: University Of California Irvine
Location: Irvine
Posted on: October 11, 2024
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Job Description:
Who We Are
Founded in 1965, UC Irvine is a member of the prestigious
Association of American Universities and is ranked among the
nation's top 10 public universities by U.S. News & World Report.
The campus has produced five Nobel laureates and is known for its
academic achievement, premier research, innovation and anteater
mascot. Led by Chancellor Howard Gillman, UC Irvine has more than
36,000 students and offers 224 degree programs. It's located in one
of the world's safest and most economically vibrant communities and
is Orange County's second-largest employer, contributing $7 billion
annually to the local economy and $8 billion statewide.
To learn more about UC Irvine, visit www.uci.edu. The School of
Medicine has recently completed construction on a new GMP Good
Manufacturing Practice) Facility). Our facility is a production
facility for the manufacturing of cellular and gene therapy
products. It includes the manufacturing space, the storage
warehouse for raw and finished product and support laboratory
areas, including quality control laboratory and quality assurance
department, to control collection, processing, storage, and release
of cell therapy products. At UCI, the GMP facility will enable
clinical trials of cell therapeutics, including stem cell
populations and bone marrow transplantation, as well as Chimeric
Antigen Receptor (CAR) T-cells. The facility includes a seven-room
GMP cellular therapy and viral vector facility, with an adjacent
quality control laboratory. Your Role on the Team
Reporting to GMP Manager the QC lead scientist will oversee the
analytical development and quality control (QC) activities to
ensure GMP compliance for UCI GMP facility products. Establish and
perform in-house assays for product release. Lead and perform a
variety of QC functions in support of the GMP facility. QC testing
will vary for each project based on the type of cells, tissues, or
organs. Lead and perform a broad range of tissue culture and
microbiological methods, utilizing good aseptic techniques and lab
practices in support of for developing, processing, and
manufacturing both research and clinical grade cellular products in
accordance to established standard operating procedures (SOP). Lead
and perform cellular, micro and molecular biology procedures
including but not limited to Western blot, Northern blot,
Polymerase chain reaction (PCR), Flow cytometry (Staining:
intracellular and surface, Acquisition and Analysis), Gene
expression analysis, DNA and RNA processing and Mammalian cell
culture. Lead environmental monitoring (EM), QC analysis, provide
technical oversite and complete routine record review of test data
and related GMP documents under moderate supervision. Must also
have the ability to perform statistical analysis to generate trend
reports on environmental monitoring and product release data, be
knowledgeable in molecular biology techniques including mRNA, DNA
extraction and RT-PCR. Will conduct investigations regarding EM
action level excursions and out of specification (OOS) results for
any QC tests executed within the GMP facility or by external
laboratories. Interact with internal and external testing service
providers to ensure quality, and review and approve third-party
assays.
Additionally, the QC lead scientist will recruit, manage, and train
QC staff for tasks in a cGMP facility. Review, revise, and develop
standard operating procedures (SOPs) as needed. Maintain up-to-date
knowledge of regulatory requirements, lab technologies, and attend
relevant training and conferences. Maintain complete documentation
as required by Federal law (21CFR 210 and 211) and adhere to
Standard Operating Procedures (SOPs). Prepare and properly store
all incoming, intermediate, and final products, apply appropriate
labels to incoming and outgoing products and monitor for proper
product labels and handling during QC testing. Perform incoming
product, in process and final product quality control tests and
maintain complete documentation throughout the manufacturing
process. Adhere to maintenance schedules and schedules preventive
maintenance, troubleshoot malfunctions and report problems, repairs
critical parts of equipment (such as media and fluid pumps,
centrifuge, autoclave issues, etc.) designated for certain
manufacturing processes and resolve unscheduled maintenance
problems. Ensure that biohazardous and other laboratory waste is
handled/emptied appropriately, and that medical waste stream rules
and regulations are enforced. Ensure that work areas and equipment
are decontaminated and disinfected observing proper changeover
procedures per SOPs. Ensure the work areas are kept clean, neat and
orderly as needed for GMP compliance and supply inventory is
maintained at appropriate levels. What It Takes to be
Successful
Total Compensation In addition to the salary range listed below, we
offer a wealth of benefits to make working at UCI even more
rewarding. These benefits may include medical insurance, sick and
vacation time, retirement savings plans, and access to a number of
discounts and perks. Please utilize the links listed here to learn
more about our compensation practices and benefits.
Required:
Preferred:
Special Conditions:
Conditions of Employment: The University of California, Irvine
(UCI) seeks to provide a safe and healthy environment for the
entire UCI community. As part of this commitment, all applicants
who accept an offer of employment must comply with the following
conditions of employment:
Closing Statement: The University of California, Irvine is an Equal
Opportunity/Affirmative Action Employer. All qualified applicants
will receive consideration for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, national
origin, disability, age or protected veteran status.
For the University of California's Affirmative Action Policy please
visit: https://policy.ucop.edu/doc/4010393/PPSM-20.
For the University of California's Anti-Discrimination Policy,
please visit:
https://policy.ucop.edu/doc/1001004/Anti-Discrimination.
We are committed to attracting and retaining a diverse workforce
along with honoring unique experiences, perspectives, and
identities. Together, our community strives to create and maintain
working and learning environments that are inclusive, equitable,
and welcoming.
UCI provides reasonable accommodations for applicants with
disabilities upon request. For more information, please contact
Human Resources at (949) 824-0500 or eec@uci.edu.Consideration for
Work Authorization Sponsorship
Must be able to provide proof of work authorization
Keywords: University Of California Irvine, Pasadena , QUALITY CONTROL LEAD SCIENTIST, Other , Irvine, California
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