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Profil #291933

Bioengineer proficient in cell culture, analytical assay development, GMP and regulatory guidelines.
Analytical development cell biology cell culture gmp cmc regulatory guidelines cell biologist quality guidelines  
Opdateret 17. november 2025
Min uddannelse
2009 - 2015

Cand.polyt. i Bioteknologi

Danmarks Tekniske Universitet - DTU

Title: "Quantitative assessment of the morphology in protein producing filamentous fungi using semi-automated image analysis"

  • Developed a semi-automated image analysis procedure for the quantification of filamentous morphology.
  • Quantified the growth and morphology of the filamentous fungus Aspergillus nidulans in submerged batch cultivation.
    • • Developed expression vectors for the construction of fungal strains with improved protein secretion.
    Uddannelsesområde: Kemi, Biotek & Materialer
    Periode: januar 2009 - januar 2015
    Min erhvervserfaring
    2023 - 2025

    Associate Scientist (temporary)

    Novo Nordisk A/S

    Development of flow cytometry screening assays for quantification of apoptosis in human cells.

  • hESC cell culture (thawing, seeding, dissociation, cryopreservation)
  • Fluorescence microscopy and flow-/image cytometry analysis
  • Development and optimization of analytical flow cytometry
    • methods
  • Documentation of method development (SOPs, lab notebooks,
    • development reports)
  • Data/statistical analysis (SAS JMP) of large data sets
  • Training of colleagues in method development, analytical software and flow cytometry and other analytical instrumens
  • Coordination with vendors for the installation and training in the use of analytical instruments
    • - Developed analytical flow cytometry live/apoptotic/dead stain method for the quantification of apoptosis in human cells
    Arbejdsområde: Forskning & Udvikling
    Periode: september 2023 - maj 2025
    2021 - 2023

    Strain Approval Scientist

    Novonesis (Novozymes)

    Cooperation with R&D strain constructors and regulatory affairs to compile documentation applying for marketing authorization for biofuels and food-/feed-/technical enzymes from governmental authorities worldwide.
    Tasks and responsibilities include:

  • Compilation of molecular biology processes translated into regulatory documentation requesting approval for food, feed and technical enzyme products
  • Communication with external stakeholders and representatives from government agencies worldwide
  • Cooperation with RA, production, R&D to align regulatory food-/feed submissions for approval in the RA employee's country
  • Agile project management
  • Bioinformatics in Python/Jupyter/CLC Bio
  • Programming in Python
    • - Created a guideline for R&D strain constructors, detailing how to construct microbial production strains complying with regulatory guidelines
    Arbejdsområde: Naturvidenskab
    Periode: august 2021 - august 2023
    2020 - 2021

    QC Stability Scientist (temporary)

    AGC Biologics

    All work according to GMP.

  • Central point of contact for receiving stability data generated in-house from analysis of small-molecule drugs sourced from clients
  • Compilation of GMP-compliant stability reports on analytical data, with subsequent delivery to clients
  • Collaboration with clients, QC and QA to verify quality of analytical data and stability reports
  • Approval and statistical analysis of in-house stability data
    • - Developed and implemented an electronic document filing system for stability reports
    Arbejdsområde: Naturvidenskab
    Periode: marts 2020 - juli 2021
    2019 - 2019

    QC Rotation Corps Chemist (temporary)

    ALK-Abello

    Position in internal rotation corps, covering for employees out of work or assisting in tasks where needed.

  • Compliance with GMP quality processes (deviations) in allergen production
  • Support to and training of operators in aseptic production
    • - Gowning for class A cleanrooms
    Arbejdsområde: Naturvidenskab
    Periode: maj 2019 - juli 2019
    2016 - 2018

    QC Analytical Chemist

    Novo Nordisk A/S

    Work in a GMP-laboratory, which analyzes haemophilia medicine by ELISA, as well as clot-/chromogenic assays and SDS-PAGE.

  • GMP compliant quality control of bioanalytical data on factor VIII haemophilia drugs
  • Writing, review and approval of technical documentation (reports, procedures, instructions and SOPs)
  • Quality processes, e.g. deviations, CR-cases, SOP updates, approval in novoLIMS
  • Deviations and systematic problem solving, via e.g. SPS, A3s, process mapping
  • Development of training material and training of laboratory technicians
  • Process improvements, e.g. via LEAN and kaizen
  • Qualification and validation of equipment and analyses
  • Data-/statistical analysis, e.g. in SAS JMP
  • IT-system manager, responsible for maintaining IT system life cycle, compiling documentation, ensuring data integrity and discontinuing redundant systems
  • Participated in working group for creation of documentation for IT systems to ensure compliance with government guidelines
    • • Initiated vendor change for purchase of control materials, reducing costs by 500,000 DKK/year
    Arbejdsområde: Naturvidenskab
    Periode: maj 2016 - november 2018
    Mine kompetencer
    Evner
    forskning metodeudvikling regulatorisk dokumentation stamceller statistik
    Sprog på arbejdsniveau
    dansk engelsk
    Mine præferencer
    Jobtype
    Fuldtidsjob Ph.d. & Postdoc Vikariat
    Arbejdsområde
    Naturvidenskab
    Geografi
    Nordsjælland Storkøbenhavn Østsjælland
    Lønønske
    55.000 DKK / måned
    Læs mere / links
    https://www.linkedin.com/in/de...
    Kontakt mig!


    HPT