cGMP Cell & Gene Therapy Specialist

UC Irvine; Irvine (CA); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Medical insurance

Retirement savings plans

Job summary

UC Irvine is seeking a scientific professional to bridge bench-top innovation and clinical-scale production within its cGMP facilities. You will lead autologous and allogeneic therapy processes, supervise staff, and drive large-scale production (20–40 L) with a focus on quality and compliance.

Responsibilities include writing and reviewing SOPs and Batch Records, maintaining rigorous documentation, and adhering to ISO cleanroom standards. A B.Sc.

Qualifications

• Strong written and verbal communication skills.
• Ability to build relationships and problem solve with internal and external teams.
• General knowledge of GMP and GLP procedures.
• Experience in writing SOPs.

Responsibilities

• Lead production activities for cell/gene manufacturing in GMP facilities.
• Develop robust processes for autologous and allogeneic therapies.
• Supervise junior staff and ensure execution of large-scale production (20–40 L).
• Maintain documentation, review test results, and ensure compliance with SOPs and quality systems.

Skills

Communication

Collaboration

Problem solving

Regulatory awareness

Education

B.Sc. degree with 3+ years experience

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 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, 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, 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.

Required

What It Takes to be Successful

• 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

• 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 [phone] or [e-mail].

Consideration for Work Authorization Sponsorship

Must be able to provide proof of work authorization