cGMP Cell & Gene Therapy Manufacturing Lead

UCI group; Irvine (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

UC Irvine is seeking a scientifically skilled professional to bridge bench research with clinical-scale GMP manufacturing of cell therapies. You will lead process development, supervise sterile production, and ensure strict GMP/GLP compliance across ISO cleanrooms.

The role demands strong collaboration, rigorous documentation, and hands-on leadership to drive autologous and allogeneic therapy workflows from development to clinical readiness at our Irvine facilities.

Qualifications

• Academic background with relevant research experience.
• Ability to build relationships and collaborate internally and externally.
• Strong oral and written communication across diverse stakeholders.
• General knowledge of GMP and GLP procedures.
• Experience in writing SOPs and maintaining Batch Records.
• B.Sc. degree with 3+ years of relevant experience.
• 3+ years of aseptic cell culture experience.

Responsibilities

• Lead design and optimization of processes for autologous and allogeneic therapies in GMP cleanrooms.
• Oversee large-scale up to 20–40 L production and provide technical leadership.
• Develop, review, and ensure compliance of SOPs and Batch Records.
• Maintain rigorous documentation per Federal and internal policies and ensure quality control.

Skills

GMP Knowledge

Aseptic Techniques

Communication Skills

Education

B.Sc. degree in a relevant field

3+ years aseptic cell culture experience

Tools

SOP Writing

Batch Records

Job description

UC Irvine is seeking a scientifically skilled professional to bridge bench research with clinical-scale GMP manufacturing of cell therapies. You will lead process development, supervise sterile production, and ensure strict GMP/GLP compliance across ISO cleanrooms.

The role demands strong collaboration, rigorous documentation, and hands-on leadership to drive autologous and allogeneic therapy workflows from development to clinical readiness at our Irvine facilities.