Senior Scientist II, PD Vector

5 months ago

London, United Kingdom Autolus Limited Full time

Role Summary 

The post holder will be  highly motivated and organised with knowledge of gene and cell therapy, process development, and biotechnology. The individual will be expected to lead a team within the function. Required technical skills include proven skills with viral vector or vaccine upstream production systems including multi-layer culture systems and Bioreactors platforms, preferably adherent cell culture. Additionally, knowledge and experience with associated analytical methods such as Cell Based Assays, Flow Cytometry, ELISA. This role requires close collaboration with other departments and team members and contribute to the development of processes suitable for cGMP manufacture of high-quality therapeutic products. 

 

Key responsibilities

  • Contribute to the strategy design and development for viral vector manufacturing projects.   
  • Collaborate with different departments within the company to obtain and/or provide detailed viral vector process development project strategy. 
  • Act as the subject matter expert for one or more aspects of the viral vector process in cross functional projects. 
  • Co-author the CMC section of regulatory submissions that support regulatory filings including INDs and BLAs. 
  • Participate in evaluation of novel technologies and automation for introduction into GMP clinical production. 
  • Develop processes suitable for the manufacturing of viral vectors.  
  • Design and perform experiments to characterize and optimize critical process parameters.  
  • Perform Design of Experiments (DoE) and statistically analyse data for viral vectors purification.
  • Design and execute experiments leading to the development and implementation of Product and Process improvements. 
  • Author development and technology transfer reports, SOPs, contribute and review BMRs, and regulatory documentation.  
  • Leading the technology transfer to Manufacturing group. 
  • Participate in meetings and leading discussions sharing results clearly and logically when required. 
  • Support instrument maintenance and calibration and general lab housekeeping.
  • Work independently with external service providers. 
  • Any other duties as required following consultation with the post holder. 
  • The post-holder will be responsible for adhering to all health and safety guidance, provided by the Company. 

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