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CSV Manager with a demonstrated history of working in the biotechnology/pharmaceutical industry. Bringing nearly 15 years of analytical experience to accurately assess, control and tests risks involved in computerised system validation.Passionate about data integrity which is the cornerstone of ensuring patient safety and product quality.Validation experience for local and server- based systems from laboratory equipment to QMS.
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Computerised Systems ManagerRoukenbio Jan 2024 - PresentMotherwell, Scotland, United Kingdom
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Computer Systems Validation ManagerSartorius Jan 2019 - Dec 2023Glasgow, Scotland, United Kingdom -
Operations Csv ManagerSartorius Stedim Biooutsource Dec 2018 - Jan 2019
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Head Of DepartmentSartorius Stedim Biooutsource Apr 2017 - Dec 2018Glasgow, United KingdomAccountable for the leadership and management of the Bioassay/ELISA team with regards to customer service, technical and regulatory standards and developing my team.Extensive experience in characterisation of mAb therapeutics.Recent expansion of role to include additional responsibilities for computer system validation. Work closely with our sales and business development teams to evaluate commercial leads whether to support biosimilar characterisation through to assay… Show more Accountable for the leadership and management of the Bioassay/ELISA team with regards to customer service, technical and regulatory standards and developing my team.Extensive experience in characterisation of mAb therapeutics.Recent expansion of role to include additional responsibilities for computer system validation. Work closely with our sales and business development teams to evaluate commercial leads whether to support biosimilar characterisation through to assay development/transfer and phase appropriate qualification/validation of assays for new biological entities. Show less
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Senior Scientist BiacoreSartorius Stedim Biooutsource Aug 2012 - Apr 2017Glasgow, UkDevelopment, optimisation and qualification of surface plasmon resonance assays (Biacore T200 and 4000) to assess comparability of biosimilar therapeutic monoclonal antibodies. Experience of both high and low affinity interaction analysis.
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Research AssistantUniversity Of Glasgow Sep 2009 - Jul 2012• Use of protein coated microcrystals (PCMCs) as novel vaccines• Collaborative study between the University of Glasgow, XstalBio Ltd. and the National Institute of Biological Standards and Control (NIBSC, World Health Organisation reference laboratory)• Key responsibilities include formulation, characterisation and testing of novel PCMC-based vaccines and characterisation of subsequent host immune response; supervision of technical staff and student projects; accurate recording and… Show more • Use of protein coated microcrystals (PCMCs) as novel vaccines• Collaborative study between the University of Glasgow, XstalBio Ltd. and the National Institute of Biological Standards and Control (NIBSC, World Health Organisation reference laboratory)• Key responsibilities include formulation, characterisation and testing of novel PCMC-based vaccines and characterisation of subsequent host immune response; supervision of technical staff and student projects; accurate recording and analysis of experimental data; regular communication of findings in both written and oral formats• Recent expansion of project to include 12 month industrial placement student at NIBSC. Responsible for project design and supervision Show less -
Industrial Placement StudentGlaxosmithkline Sep 2004 - Sep 2005Stevenage, United Kingdom• Dissection of the individual contributions of the C3a and C5a anaphylatoxins to inflammatory cytokine release in whole blood• Development of a whole blood assay to determine in vitro cytokine release• Development, validation and launch of an 8-plex Luminex• Introduction of Luminex technology to the Asthma Biology CEDD • Regular reporting of research findings to the research group as both written and oral reports• Altering project direction as appropriate in keeping with… Show more • Dissection of the individual contributions of the C3a and C5a anaphylatoxins to inflammatory cytokine release in whole blood• Development of a whole blood assay to determine in vitro cytokine release• Development, validation and launch of an 8-plex Luminex• Introduction of Luminex technology to the Asthma Biology CEDD • Regular reporting of research findings to the research group as both written and oral reports• Altering project direction as appropriate in keeping with GSK’s mission statement• Effective time management to ensure that work was completed to specific deadlines Show less
Sarah Stone Skills
Sarah Stone Education Details
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Pass (Unstratified Results)
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First Class Honours -
The Nobel School, Stevenage
Frequently Asked Questions about Sarah Stone
What company does Sarah Stone work for?
Sarah Stone works for Roukenbio
What is Sarah Stone's role at the current company?
Sarah Stone's current role is Excited by Data Integrity and System Validation.
What is Sarah Stone's email address?
Sarah Stone's email address is sa****@****rce.com
What schools did Sarah Stone attend?
Sarah Stone attended The University Of Glasgow, The University Of Glasgow, The University Of Manchester, The Nobel School, Stevenage.
What skills is Sarah Stone known for?
Sarah Stone has skills like Microbiology, Cell Culture, Cell Biology, Elisa, Life Sciences, In Vitro, Cell Based Assays, Vaccines, Pcr, Western Blotting, Assay Development, Cell Signaling.
Not the Sarah Stone you were looking for?
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Sarah Dodd
United Kingdom -
Sarah Stone
London -
Sarah Stone
Leigh-On-Sea2hotmail.com, konicaminolta.co.uk2 +448008XXXXX
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Sarah Stone
Helping Organisations Identify What Social Value Is And How To Create It. Always Looking For Practical Ideas For New Ways To Deliver Social Value.United Kingdom1samtaler.co.uk -
2yahoo.co.uk, nortonrosefulbright.com
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