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 lead scientist, the candidate will play a key scientific role in bridging the gap between bench-top innovation and clinical-scale production with duties spanning across process development and GMP manufacturing. 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. Ability to work in an independent fashion with minimum daily supervision on the manufacturing of biological products is necessary.

Candidates must demonstrate strong knowledge of aseptic behaviors and techniques, as well as a solid understanding of regulations and workflow requirements within ISO 5, ISO 7, and ISO 8 cleanroom environments. The ideal candidate will be capable of leading junior specialists and ensuring successful execution of production activities including large scale production (20-40L scales). Experience in creating, writing, and reviewing Standard Operating Procedures (SOPs) and Batch Records is highly preferred. Successful candidates will exhibit excellent problem-solving skills, a high level of attention to detail, and a collaborative mindset that supports effective teamwork.

Specific duties for cell and gene manufacturing include design robust processes for autologous and allogeneic therapies while providing hands-on technical leadership within our state-of-the-art cleanroom facilities. Additionally, manufacturing GMP grade formulations, storing them under GMP conditions and preparing final formulations for patient administration, reviewing test results according to laboratory policy and procedure, and verifying results, monitoring for completeness, accuracy, clinical validity, legibility, documentation, and transcription errors.

Specific duties for laboratory maintenance and documentation include maintaining complete documentation as required by Federal law (21CFR 210 and 211), adhering to Standard Operating Procedures (SOPs), preparing and properly storing all incoming, intermediate and final products, performing all product manufacturing duties in the GMP facility while fully gowned, appling appropriate labels to incoming and outgoing products and monitoring for proper product labels and handling during manufacturing, maintaining complete documentation throughout the manufacturing process, adhering to maintenance schedules and scheduling preventive maintenance, troubleshooting malfunctions and reporting problems, ensuring that biohazardous and other laboratory waste is handled/emptied appropriately, and that medical waste stream rules and regulations are enforced, ensuring that work areas and equipment are decontaminated and disinfected observing proper changeover procedures per SOPs, and ensuring supply inventory is maintained at appropriate levels.

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.
• General knowledge of GMP and GLP procedures
• Experience in writing SOPs
• B.Sc. degree with more than 3 years of relevant experience.
• 3+ years of aseptic cell culture (human primary cells and/or human cell lines) is required

Preferred:

• Demonstrated experience supervising staff and students in an academic or research setting.
• Demonstrated leadership skills including effective communication, negotiation, coaching, and conflict resolution.
• Experience with bioreactors; AAV and TFF
• Familiarity with regulatory affairs, quality control and production
• Experience with Process Development
• 2 years of experience working in GMP facility

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

Consideration for Work Authorization Sponsorship

Must be able to provide proof of work authorization