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Head of Cell Culture

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JOB OVERVIEW

Our Client strives to become a world leader in biologics CDMO. Providing first-class, large-scale biologics CDMO services to international biotech companies. Their clients can rely upon the most advanced equipment and process design, a world-class management team, and services tailored to client needs. The company has built a global management team with industry veterans, and other pharma giants. Working with global partners, the company is also building the first AI-Supported Smart Bio-Factory in Asia. Based on Digital 4.0 principles, are combining the power of IoT, augmented data analytics, and autonomous manufacturing systems, to revolutionize biologics CDMO services. Our Client is the first in China to utilize the 15kL bioreactor, driving production cost down significantly. In addition, the company is working with leading institution investors to establish VC funds of up to 10Bn RMB in total size, focusing on biomedicine projects.

Skills Required

Bioengineering, biotechnology and other related majors, with more than 8 years of  work experience in undergraduate, and at least 5 years of experience in cell culture  management 

Highly experienced in upstream manufacturing in a GMP environment

Experience in the scale-up and tech transfer of biologics in the biopharmaceutical  industry  

Have a deep understanding of culture process, and be proficient in the process and operation of cell culture including, media preparation, vial thawing/expansion, bioreactors (pilot-scale disposable / stainless steel bioreactors), centrifugation, depth filtration, and related analytical instruments

Familiar with international GMP regulations and guidelines

Key skills and experience

  • Assist in the design, construction, and validation of new monoclonal antibody production line cell culture equipment and facilities to meet global regulatory requirements
  • Responsible for the operation of GMP production and upstream workshop
  • Serve as the technical lead for the upstream production of biopharmaceutical GMP  factories and processes, from validation to GMP production
  • Build and improve the cell culture process platform, and serve as the manufacturing lead for scale-up and tech transfer of the cell culture process 
  • Coordinate and cooperate with various functional teams of the CMC development  department
  • Communicate with current and potential future clients as the upstream manufacturing technical lead
  • Support regulatory filings and inspections

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