Senior Development Scientist

1 month ago

London, Greater London, United Kingdom Autolus Limited Full time

Role Summary:

The post holder will be a highly motivated and organized individual with knowledge of gene and cell therapy, process development, and biotechnology. The individual will be expected to lead a team within the function 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 analyze 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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