cGMP QC Junior Specialist

Req ID: 139486
Location: Irvine, California
Division: School of Medicine
Department: CGMP Facility
Position Type: Full Time
Salary Range Minimum: USD $30.15/Hr.
Salary Range Maximum: USD $48.51/Hr.

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 cGMP Facility, following Current Good Manufacturing Practices (cGMPs). A cGMP facility is a production facility for the manufacturing of pharmaceutical or cellular products. It includes the manufacturing space, the storage warehouse for raw and finished product and support laboratory areas, including quality control and quality assurance programs, to control collection, processing, storage and release of cell therapy products. At UCI, the cGMP 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 the cGMP Quality Control lead scientist, the candidate will assist in executing the translational development strategy, along with supporting the project development and quality control testing for multiple projects in the GMP Facility. A background in nonclinical development for gene and/or cell therapies and a proven ability to advance novel therapeutic approaches into clinical development is highly desirable.

Specific duties include assisting in manufacturing of GMP grade cell lines for gene therapy vector production, in manufacturing, purifying, and characterizing gene therapy vectors (ex. lenti, retro, AAV), in manufacturing GMP grade human multipotent stem cells (ex. MSCs and HSCs) and GMP grade hESC and iPSCs, in performing analyses for identity and functionality on GMP grade iPSCs, hESCs and differentiated tissues using immunofluorescent stains, PCR, and other laboratory tests.

Additionally, the candidate will support the process and analytical development, validation, and qualifications tasks associated with any cGMP project. Assists in performing project related techniques in accordance to established standard operating procedures (SOP) with accurate documentation and assists cross functional teams with required activities. May contribute to writing or aiding in the writing of SOPs for the project. Performs routine laboratory tasks and procedures, including but not limited to equipment, routine maintenance and environmental monitoring.

Specific duties for laboratory maintenance and documentation include maintaining complete documentation as required by Federal law (21CFR 210 and 211), following Standard Operating Procedures (SOPs) and adhering to Good Documentation Practices, assisting in the preparation and proper storage all incoming, intermediate and final products, assisting with all product manufacturing duties in the GMP facility, applying appropriate labels to incoming and outgoing products and monitoring for proper product labels and handling during manufacturing, maintaining complete documentation throughout the manufacturing process, reporting problems, ensuring that biohazardous and other laboratory waste is handled/emptied appropriately, and that medical waste stream rules and regulations are enforced, and ensuring that work areas and equipment are decontaminated and disinfected observing proper changeover procedures per SOPs.

Candidates must be strong team players who thrive in a fast-paced environment. They should be capable of prioritizing tasks effectively while supporting multiple projects simultaneously. Ideal candidates should demonstrate solid technical proficiency, along with strong analytical skills, attention to detail and adherence to established quality standards and regulatory requirements. They should be able to perform accurate testing and documentation and identify and troubleshoot routine issues with supervision. Candidates are expected to support continuous improvement initiatives, collaborate effectively with cross-functional teams, and maintain a safe, compliant, and organized laboratory environment.

What It Takes to be Successful

Required:

• Academic background and experience in relevant area of research.
• Ability to build relationships, collaborate and problem solve both internally and with external organizations.
• Advanced oral and written communication skills with the ability to communicate effectively with diverse stakeholders.
• Demonstrated knowledge university, state, and federal policies that influence higher education.
• 2+ years of aseptic cell culture (human primary cells and/or human cell lines) is required
• General knowledge of GMP and GLP procedures
• Experience in writing SOPs
• B.Sc. in a related field or the equivalent combination of education and relevant experience.

Preferred:

• Demonstrated experience supervising staff and students in an academic or research setting.
• Experience with bioreactors; AAV and TFF
• Familiarity with regulatory affairs, quality control and production
• Experience in biological and analytical techniques, including microbiology, cellular biology, molecular biology, and related assays (e.g., Grma Staining, qPCR, flow cytometry, ELISA, spectrophotometry, mammalian cell culture).
• 1 year of experience working in GMP facility preferred

Special Conditions:

• Is required to lift up to 20lbs
• Must be able to work safely with chemicals and hazardous materials
• Must be able to work overtime and flexible shifts

Total Rewards

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.

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:

• Background Check and Live Scan
• Employment Misconduct*
• Legal Right to work in the United States
• Vaccination Policies
• Smoking and Tobacco Policy
• Drug Free Environment

*Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.

The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.

• California Child Abuse and Neglect Reporting Act
• E-Verify
• Pre-Placement Health Evaluation

Details of each policy may be reviewed by visiting the following page - https://hr.uci.edu/new-hire/conditions-of-employment.php

Closing Statement:

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC Anti-Discrimination Policy.

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

To apply, visit https://jobs.uci.edu/careers-home/jobs/139486







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