Cell / Gene Therapy Product Production Responsible Person

Job Responsibilities:

• Comprehensive leadership and management of the production team for cell therapy and gene therapy products, coordinating the full process from pilot scale to industrial mass production.

• Lead production site planning, GMP-level factory renovation, and the establishment and validation of core production facilities (including closed bioreactors, purification systems, aseptic filling lines, etc.).

• Lead viral vectors (such as lentiviral LV, adeno-associated virus AAV) or cellular therapies (such as CAR-T, TCR-T, mesenchymal stem cells) process development, process characterization, process validation, scale-up, and definition and control of critical quality attributes (CQA) and critical process parameters (CPP).

• Develop and implement annual/qtr production plans, coordinate raw material supply, equipment maintenance, quality assurance and regulatory compliance resources, ensure batch stability and timely delivery of clinical and commercial products.

• Establish and continuously optimize the production standard operating procedures (SOP), batch record templates, deviation and change management processes, and strengthen product quality culture and compliance awareness for cell/gene therapy products.

Requirements:

• Have a PhD in biotechnology, cellular biology, microbiology, bioengineering or related fields; more than 10 years of cell therapy or gene therapy industry practical experience, of which at least 5 years are as production manager or technical responsible position.

• Have complete industrial production experience in large-scale production of viral vectors (LV/AAV), or autologous/allogeneic cell therapy (such as CAR-T, TCR-T, pluripotent/differentiated stem cells), and be familiar with the ATMPs regulatory framework and ICH Q5 series guidelines.

• Proficient in GMP regulations (including FDA 21 CFR Part 11 & 210/211, EU Annex 1 & 2, Chinese NMPA GMP appendix for cell therapy products and Hong Kong Pharmacy and Poisons Ordinance related requirements), with successful experience in passing drug regulatory agency on-site inspections.

• Holding a Hong Kong permanent resident identity, or meeting the eligibility criteria for Talent Pass, Elite Pass, IANG, Dependent visa or other legal work qualifications; having excellent team leadership, cross-functional coordination and emergency situation decision-making abilities.