Nicole Spada

Team Lead Analytical Development Cell Biology at Ascend Gene & Cell Therapies
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Contact Information
us****@****om
(386) 825-5501
Location
DE

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Experience

    • United Kingdom
    • Biotechnology Research
    • 1 - 100 Employee
    • Team Lead Analytical Development Cell Biology
      • Feb 2023 - Present

    • United Kingdom
    • Biotechnology Research
    • 1 - 100 Employee
    • Team Lead Analytical Development - Cell Biology
      • Jan 2020 - Feb 2023

      Manage and advance a sub-department for analytical development and tech transfer in the expertise area of cell biology including technical and managerial responsibility for stuff. Development and optimization of assays for rAAV efficacy by means of parallel line analysis includind all relevant statistical data evaluations (relative potency Assay). Qualification of assays and lead of validation at external partners.Development of internal cell based assays for product characterisation and /or QC release. Development of alkaline gel method to analyze the integrity of rAAV. Development of qPCR methods like genome Titer determination.In-house qualification of methods as well as lead and support of validation at external partners. Method transfer to CMOs/CROs for ph1-3 and commercial activities. SME for validation activities, justification of specifications, release testing, trending, investigations and continuous improvement. Preparation and review of work instructions, qualification and validation plans, development, qualification and validation reports. Support in the preparation of regulatory documents. Representing a project team or member of cross functional agile teams. Provide recommendations to strategic decisions in the expertise area of cell biology.

    • Scientist Analytical Development
      • Sep 2017 - Dec 2019

      AAV based gene therapy, development of cell-based, molecular biological and proteinbiochemical assays for characterization of viral vectors (from TOX to clinics), method transfer to CROs, GLP&GMP

    • Technical Assistant Assay Development
      • Jan 2016 - Aug 2017

      AAV based gene therapy, development of cell-based, molecular biological and proteinbiochemical assays for characterization of viral vectors (from TOX to clinics)

    • Germany
    • Research Services
    • 700 & Above Employee
    • Scientist Molecular Epidemiology
      • Jul 2010 - Dec 2015

      Genotyping (Sequenom, Illumina) – epigenetics (Epityper-Sequenom, Pyrosequencing), Sanger sequencing, qPCR, quality survey of DNA and RNA, quality management Genotyping (Sequenom, Illumina) – epigenetics (Epityper-Sequenom, Pyrosequencing), Sanger sequencing, qPCR, quality survey of DNA and RNA, quality management

    • Germany
    • Higher Education
    • 700 & Above Employee
    • Scientist Epigenetics
      • Jun 2008 - Jul 2009

      Cultivation of embryonic stem cells and different mouse cells, cloning, cell fixation and confocal microscopy including live cell imaging Cultivation of embryonic stem cells and different mouse cells, cloning, cell fixation and confocal microscopy including live cell imaging

Education

  • Ludwig-Maximilians Universität München
    Diplom, Biologie, allgemein
    2001 - 2006
  • Gabriel-von-Seidel Gymnasium Bad Tölz
    Abitur

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