Senior cGMP Cell & Gene Therapy Lead

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

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.