Job Spec

Role and Responsibilities

• Supervise, train and mentor cell processing staff, creating a high performing team
  
• Design and execute primary cell culture development studies, procure critical reagents, generate cell banks and manage cell culture operations (daily monitoring, troubleshooting and investigations)
  
• Author required documentation relating to process development and technology transfer activities in an accurate and timely manner. Such documentation includes (but not be limited to) Technical reports, SOPs and Logbooks
  
• Perform routine in vitro assays used to characterise cell product quality, including Flow Cytometry and ELISA assays
  
• Support day-to-day research activities including design, execution, statistical data analysis and interpretation of scientific experiments
  
• Collect and analyse data, track and trend cell culture data and establish specifications for critical process controls
  
• Support technology transfer activities to external parties evaluating their technology
  
• Presents findings at group meetings and work closely with cross-functional teams
  
• Communicate information on current process data which may impact process development and/or technology transfer
  
• Provide technical input/guidance relating to the company’s cell culture facility development
  
• Liaise and communicate with Project Lead and Snr Director Process Development
  

Person Spec

·Degree in Cell Biology, Immunology, Bioengineering, Biomedical engineering or related discipline; BS with 5-6 years of relevant experience, MS with 3-4 years of experience, or PhD with 2+ years of relevant experience in a biotechnology or cell therapy industry

·Experience with mammalian cell-culture process development for cell therapy, biologics or vaccines (experience with T-cell or other immune cell cultures is preferred)

·Prior experience primary immune cells, iPSCs highly preferred but not essential

·Experience interpreting analytical methods used to characterize immune cell-based therapies, including flow cytometry, ELISA, PCR, western blotting and cell-based methods

·Must be highly motivated, a team player and able to deliver on defined timelines, in collaboration with colleagues

·Requires excellent troubleshooting skills, creative thinking, and understanding of the principles of experiment design and statistical analysis

·Proven ability to be highly productive and successful in a high pace work environment

·Excellent attention to detail and meticulous bench work with a solid understanding of aseptic techniques and technologies in cell culture

·Skilled in initiating and managing projects of complex scope, having cross-functional impact

Desirable Skills

• Experience with cell culture process development and ATMP manufacturing requirements
• Familiarity with analytical methods used to release and characterize cell-therapy based modalities
• Prior experience with plate and cell-based assays including techniques such as molecular biology, digital and quantitative PCR, NGS, western blotting, and ELISA desirable
• Experience/understanding of operating within a Good Manufacturing Practice (GMP) environment, including aseptic processing

Skill and Competencies

• Demonstrated problem-solving/troubleshooting capability
• Excellent interpersonal skills and communication skills, both verbal and written
• Capability to work collaboratively as part of a multi-disciplinary team with other scientists, engineers, and project managers
• Ability to develop study designs, workstreams, timelines and deliverables while driving project execution to meet corporate expectations