cGMP Cell & Gene Therapy Specialist

UCI group; Irvine (CA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Medical Insurance

Retirement Savings Plans

Paid Time Off

Job summary

UC Irvine is seeking a cGMP MSAT Manager to bridge bench innovation and clinical-scale production in cell therapy. The role focuses on transfer, validation, and optimization of manufacturing processes and analytical methods, including scale-up of 20–40L, within ISO 5/7/8 cleanrooms.

The candidate will mentor junior staff, drive continuous improvement, and ensure compliance with GMP/GLP standards while collaborating with cross-functional teams in a fast-paced academic setting.

Qualifications

• 3+ years of aseptic cell culture (human primary cells and/or human cell lines) experience.
• General knowledge of GMP and GLP procedures.
• Experience in writing SOPs.
• Experience with Process Development.
• B.Sc. in science, biochemistry or equivalent, or B.Sc. with >3 years relevant experience.

Responsibilities

• Serve as the technical bridge between bench-top innovation, process development, analytical development, and clinical-scale production.
• Provide oversight to ensure transfer, validation, and optimization of manufacturing processes and analytical methodologies, including large-scale productions (20–40L).
• Lead process scale-up initiatives and integrate analytical assays for process monitoring.
• Spearhead root-cause investigations for deviations and implement continuous improvement to enhance yield and efficiency.
• Mentor junior specialists to ensure flawless daily production and testing activities.
• Support nonclinical/preclinical development for cell and gene therapies and regulatory workflows in ISO cleanrooms.

Skills

Aseptic cell culture

GMP/GLP knowledge

SOP writing

Process development

Communication skills

Education

B.Sc. in science/biochemistry or equivalent

B.Sc. with 3+ years GMP experience

Job description

Overview

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.

Responsibilities

Reporting to the cGMP MSAT Manager, the candidate serves as the critical technical bridge between bench-top innovation, process development, analytical development, and clinical-scale production. In this role, the candidate will provide advanced technical oversight to ensure the seamless transfer, validation, and optimization of both manufacturing processes and analytical methodologies, including but not limit to large-scale productions of 20–40L. The ideal candidate will lead process scale-up initiatives, integrate robust analytical assays for process monitoring, evaluate production data for consistency, spearhead root-cause investigations for complex manufacturing deviations, and implement continuous improvement strategies to enhance product yield and operational efficiency. Additionally, the candidate will be responsible for leading and mentoring junior specialists to ensure the flawless execution of all daily production and testing activities. To be successful, candidates must have a strong background in nonclinical/preclinical development for cell and gene therapies, alongside a proven ability to advance novel therapeutic approaches into clinical development. Exceptional expertise in aseptic behaviors and techniques is mandatory, as is a comprehensive understanding of analytical development frameworks and regulatory/workflow requirements within ISO 5, ISO 7, and ISO 8 cleanroom environments. This position requires hands‑on experience creating, writing, and reviewing Standard Operating Procedures (SOPs), Batch Records, and technical protocols or regulatory filings to maintain strict compliance with global cGMP guidelines. Strong problem‑solving skills, rigorous attention to detail, and a collaborative mindset are essential for success in this high-impact, cross‑functional role.

Qualifications

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.


• 3+ 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


• Experience with Process Development


• B.Sc. in science, biochemistry or equivalent.


• B.Sc. degree with more than 3 years of relevant experience.


• 2 years of experience working in GMP facility preferred

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

Special Conditions:

• Is required to lift up to 20lbs


• Frequent walking; Some reaching, stooping, bending, kneeling, crouching


• Tasks require focused attention to details


• 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 [phone] or [e-mail].