Sarah Dalby-Chung

Experience

• 

  Sanofi

  Oct 2011 - Mar 2012

  Associate Microbiologist (SRG)

  Quality assurance microbiologist employed by SRG on a temporary basis. Part of Quality Assurance. Was part of the environmental monitoring team in Microbiology and also trained to carry out identification of bacteria using biochemical methods and Vitek.

• 

  AstraZeneca

  Mar 2012 - now

  A Scientist role in Pharmaceutical Technology and Development, part of Product Development. I support a range of products in early and later stage development from a microbiological perspective. I have given advice on microbiological testing (including testing on stability) and reviewed validation protocols. I suggest different tests that are required - enumeration, specified organism tests, water activity, mould challenge, microbial challenge study, sterility and endotoxin testing based on the formulation of the product and the stage of development. I also use the relevant Pharmacopoeia (for instance United States Pharmacopoeia, European Pharmacopoeia and Japanese Pharmacopoeia) to set microbiological specifications on Total Aerobic Microbial count and Total Combined Yeast and Mould count. In addition, I review microbiology results and ensure they are within Pharmacopoeial specifications. I also look for out of trends and out of specifications on release testing and on stability.I have assisted a deviation facilitator on determining a root cause for a microbiology deviation and suggested CAPAs to put in place. I have carried out risk assessment on my projects and worked with members of project teams to make microbiological decisions. I work with colleagues across a number of disciplines. The role also involves working with contract research organisations and contract manufacturers to ensure products adhere to the appropriate quality, as suggested by pharmacopoeial and regulatory recommendations. This involves manufacturing risk assessment and having knowledge of manufacturing processes for drug product and active pharmaceutical ingredients, with consideration of microbiological controls. I have also been involved with authoring and reviewing the microbiological attributes sections of regulatory submissions. Show less

  • Quality Supplier Manager

    Mar 2023 - now

  • Quality Advisor

    Oct 2020 - Mar 2023

  • Senior Scientist (Microbiologist R&D)

    Oct 2019 - Oct 2020

  • Pharmaceutical Development Microbiologist (R&D)

    Jul 2015 - Oct 2019

  • QC Microbiology Laboratory Technician

    Mar 2012 - Jul 2015