Senior Scientist II (ASAT)

This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Role Summary

The post holder will be part of the ASAT function which falls under the wider Quality Control department. The post holder will work on supporting the delivery of analytical procedures to enable the release and stability testing of autologous CAR T-cell products for clinical trials and commercial supply in the near future. The Senior Scientist II is responsible for working in cross functional teams to execute analytical procedures development, validation and implementation into the QC Operations laboratories or Autolus CROs/CDMOs. The post holder will represent Autolus when interacting with external laboratories and will lead activities associated with analytical procedures implementation, troubleshooting or tech transfer. This role will be based in Autolus Manufacturing site in Stevenage, UK

Key Responsibilities

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  Act as subject matter expert (SME) for QC analytical procedures / techniques and quality events.

  
  

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  Support the transfer of analytical procedures from Analytical Development to QC (internal or external) and subsequent qualification and validation activities by leading specific tasks and activities closely with lead scientist(s)

  
  

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  Lead investigations for quality events for non-conformances and change controls relating to assay validation activities

  
  

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  Troubleshoot assay performance issues as and when required

  
  

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  May act as the QC subject matter expert in cross functional projects for early and late phases of development

  
  

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  May participate in CMC activities to represent QC function where required

  
  

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  Support management of stability programmes for drug product and other critical materials

  
  

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  Author analytical protocols and reports, and regulatory documentation as required

  
  

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  Complete QC sections of product quality reviews

  
  

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  Lead/support the implementation or update of the quality systems required for QC

  
  

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  Lead and support equipment qualification activities

  
  

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  Support, train and mentor junior members of the team

  
  

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  Work with external QC service providers as required

  
  

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  Adhering to all health and safety guidance, provided by the Company

  
  

Demonstrated skills and competencies

E – Essential P – Preferred

Experience

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  Directly relevant biotechnology or pharmaceutical industry experience - >6 years (E)

  
  

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  Experience of working in a fast-paced laboratory environment (E)

  
  

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  Experience of training, mentoring and supervision of junior laboratory staff (E)

  
  

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  Minimum of 5 years’ experience in a GMP QC laboratory (P)

  
  

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  Experience in analytical procedure development (P), transfer, validation and routine execution (E)

  
  

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  Working knowledge of biostatistics/Trend (E)

  
  

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  Experience working with external QC service providers (P)

  
  

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  Understanding of the CMC as applied to biologics and ATMPs (P)

  
  

Qualifications

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  Degree or higher degree in Biology/Biomedical Science/Immunology or related discipline (E)

  
  

Skills/Specialist knowledge

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  Ability to act as a SME within a range of biopharmaceutical and cell-based techniques including at least 3 of: qPCR, Flow cytometry, Aseptic technique, Sterility testing, Mammalian cell culture, Potency testing testing (E)

  
  

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  Excellent understanding of cell biology and immunology (E)

  
  

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  Strong verbal and written communication skills (E)

  
  

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  Flexible, self-motivated and focused on team outcomes (E)

  
  

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  Understanding of and excellent familiarity with GMP regulations (E)

  
  

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  Excellent organisational skills with the ability to present results clearly and logically, working co-operatively as part of a team as well as independently (E)

  
  

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  Excellent attention to detail and ability to accurately follow and define SOPs (E)

  
  

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  Ability to identify and implement solutions (E)

  
  

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  Advanced knowledge of late phase analytical procedure development (P) and validation (E)

  
  

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  Advanced knowledge of the relevant analytical regulatory requirements for commercial QC testing of biopharmaceuticals (E) or ATMPs (P)

  
  

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  Scientific expertise in Quality control methodologies and strategies applied to biologics and ATMPs (E)