Thor Skovsted Email & Phone Number

Sønderborg, Region Syddanmark, Danmark

Responsibility:Document and insure high quality assay performance of blodsamples in Sygehus Sønderjylland- Quality responsible biochemist for protein electrophoresis- Quality responsible biochemist for bloodgas analysis- Quality responsible biochemist for hemostasis- Quality responsible biochemist for heamatology- Quality responsible biochemist for allergy assays- Quality responsible biochemist for autoimmunologyAchivements:Author of a validation report… Show more Responsibility:Document and insure high quality assay performance of blodsamples in Sygehus Sønderjylland- Quality responsible biochemist for protein electrophoresis- Quality responsible biochemist for bloodgas analysis- Quality responsible biochemist for hemostasis- Quality responsible biochemist for heamatology- Quality responsible biochemist for allergy assays- Quality responsible biochemist for autoimmunologyAchivements:Author of a validation report of ABL 835 bloodgas analyzer Show less

Marielundvej 25, 2730 Herlev

Responsibility:• Manager of production Support (aseptic GMP production)• Manage the Support to Large volume and Small volume production• Prioritise departement tasks and plans• Employee and management meetings (one-to-one meetings)• Deparment meetings• Hiring new employeeAchivements:• Established a 4 week planning board for Support task planning• Established one-to-one meetings• Hiring several academic employees in to Support• Qualified in… Show more Responsibility:• Manager of production Support (aseptic GMP production)• Manage the Support to Large volume and Small volume production• Prioritise departement tasks and plans• Employee and management meetings (one-to-one meetings)• Deparment meetings• Hiring new employeeAchivements:• Established a 4 week planning board for Support task planning• Established one-to-one meetings• Hiring several academic employees in to Support• Qualified in review of batch journal of Sterile Serial Production GMP Documents Show less

Måløv

Responsibility:• Develop and validate assay for drug product (DP) and drug substance (DS) for GMP. • Statistical data analysis and write validation reports (and SOP’s) approved by QA. • Write Change Request (CR-cases) for QA approval. • Automate laboratory analysis and implement new equipment for GMP. • Support technicians in analysis of DP/DS samples. • Approve assay result in LIMS. Achievements: • Developed a fully automated potency assay for… Show more Responsibility:• Develop and validate assay for drug product (DP) and drug substance (DS) for GMP. • Statistical data analysis and write validation reports (and SOP’s) approved by QA. • Write Change Request (CR-cases) for QA approval. • Automate laboratory analysis and implement new equipment for GMP. • Support technicians in analysis of DP/DS samples. • Approve assay result in LIMS. Achievements: • Developed a fully automated potency assay for modified rFVIIa on ACL TOP, IL. The assay is clotting assay developed with automated (Biomek-robot) pre-dilution of samples.• Developed and validated a potency assay to modified coagulation Factor IX (FIX) on ACL TOP. • Authored the CR-cases for GMP implementation of two new ACL TOP equipments and the validated potency assay. • Expert reviewer of qualification documents (e.g. IQ/OQ/PQ plans and reports) approved by QA.• Developed a plate assay (96-well) automated on a Hamilton Star robot. • Authored the GMP qualification documents for the Hamilton robot and performed IQ/OQ/PQ, and developed (dye and gravimetric) methods to estimate precision and accuracy. • Validated a potency (clotting) assay for a modified DP formulation of rFVIIa on ACL Elite Pro.• Managed installation of a Hamilton robot in the laboratory.• Assay responsible scientist for 3 chromogenic FIX assays and 3 clotting assay and approve results in LIMS (GMP and non-GMP)• Supported technicians in 3 chromogenic FIX assays and 3 clotting assay Show less

Responsibility:• Overall quality responsibility for obtaining and maintaining DANAK accreditation in the following areas and analytical platforms:o General chemistry (part of): Cobas Intergra, replaced by Cobas 6000.o Hematology: Sysmex XE-2100, replaced by XE-5000.o Coagulation: Sysmex CA-1500, replaced by ACL TOP.o Urine Analysis: KONE lab, replaced by Cobas 6000.o Hormones and antibodies/antigens: Architect immunoassays.o Auto immune anti-bodies:… Show more Responsibility:• Overall quality responsibility for obtaining and maintaining DANAK accreditation in the following areas and analytical platforms:o General chemistry (part of): Cobas Intergra, replaced by Cobas 6000.o Hematology: Sysmex XE-2100, replaced by XE-5000.o Coagulation: Sysmex CA-1500, replaced by ACL TOP.o Urine Analysis: KONE lab, replaced by Cobas 6000.o Hormones and antibodies/antigens: Architect immunoassays.o Auto immune anti-bodies: ImmonCAP-250/Themo, new assay.• Laboratory Safety Manager.• Supervisor for education of bachelor students. Achievements:• Validation of a new autoimmune IgG-antibody assay CTD-screening (immunoCap250) and DANAK accreditation. • Validation and assay transfer from Sysmex XE-2100 to XE-5000 (hematology) and achieved DANAK accreditation.• Assay transfer of Citrate measured in urine from KONE lab to Cobas 6000, C501 (open channel application kit).• Development of a new assay to determine viscosity in joint fluid using RheoRox (bachelor project).• Establishing AT and PS coagulation assays for analysis of non-human plasma samples on ACL TOP. • Principal investigator of two non-clinical studies applying coagulation assays (AT and PS on ACL TOP) performed in collaboration with Novo Nordisk A/S.• Validation and transfer of specific protein assays from Cobas Integra to Cobas 6000, c501 and DANAK accreditation. • Validation of coagulation assays transferred from Sysmex CA-1500 to ACL TOP and DANAK accreditation.• Specialist (education for chemist) in Clinical Biochemistry in Danish Society of Clinical Biochemistry, (DSKB, UUII). • European certification in EC4 registry as Clinical Biochemist (EurClinChem). Show less

Responsibility: • Develop and validate activity assays and anti drug antibody (ADA) neutralising assays. • Study director and principal investigator in clinical and non-clinical GLP studies. • Qualify and implement new equipment for analyses in a GLP environment. Achievements: • Development and validation of a FVII-neuralising antibody assay (study director).• Principal investigator of a FVII-neuralising antibody assay for clinical and non-clinical studies.•… Show more Responsibility: • Develop and validate activity assays and anti drug antibody (ADA) neutralising assays. • Study director and principal investigator in clinical and non-clinical GLP studies. • Qualify and implement new equipment for analyses in a GLP environment. Achievements: • Development and validation of a FVII-neuralising antibody assay (study director).• Principal investigator of a FVII-neuralising antibody assay for clinical and non-clinical studies.• Qualification (IQ/OQ/PQ) of KONE Lab, ACL 10000, and ACL Advanced instruments for GLP. • Development and validation of a FXIII activity assay for clinical and non clinical use. • Assay transfer of the FXIII activity assay to a CRO.• In vitro spike experiments for comparison of two FVII coagulation assay (results published in a scientific paper). • Transfer of the FVIIa coagulation assay to a CRO laboratory in Hamburg, Germany. • Technical auditor to support GLP QA in audit of coagulation assays in 2 CRO laboratories. • Developed a bridging ELISA for determination of ADA against FIX applied for non-clinical studies. Show less

Responsibility: • Perform a clinical study with MBL ELISA. • Develop and implement new equipment for gel-scanning of SDS-PAGE.• Supervise 2 technicians. Achievements:• A clinical study of 3000 samples was performed on Biomek robots with MBL ELISA and data collected into a database.• Comparison of MBL concentrations in plasma and serum samples. • Development and implementation of Bio-Rad gel-scanning equipment for determining relative distribution of… Show more Responsibility: • Perform a clinical study with MBL ELISA. • Develop and implement new equipment for gel-scanning of SDS-PAGE.• Supervise 2 technicians. Achievements:• A clinical study of 3000 samples was performed on Biomek robots with MBL ELISA and data collected into a database.• Comparison of MBL concentrations in plasma and serum samples. • Development and implementation of Bio-Rad gel-scanning equipment for determining relative distribution of monomer, polymers of MBL in SDS-PAGE. Show less

Responsibility: • Overall quality responsibility in the following areas and analytical platforms: • General chemistry (part of): o Cobas Mira, replaced Cobas Intergrao Cobas Fara, replaced by Beckman, Array (nephlometer)o Hematology: Advia H3, replaced by Sysmex XE-2100o Urine Analysis: Gelelectrophoresiso Allergy screening and specific IgE: ALK, Magic Lite replaced by ImmonCAP• PhD educationAchievements: • Developed the laboratory from a… Show more Responsibility: • Overall quality responsibility in the following areas and analytical platforms: • General chemistry (part of): o Cobas Mira, replaced Cobas Intergrao Cobas Fara, replaced by Beckman, Array (nephlometer)o Hematology: Advia H3, replaced by Sysmex XE-2100o Urine Analysis: Gelelectrophoresiso Allergy screening and specific IgE: ALK, Magic Lite replaced by ImmonCAP• PhD educationAchievements: • Developed the laboratory from a routine laboratory in allergy into an allergy research laboratory.• Established and developed the following new methods in the laboratory related to allergy testing: • Method for extraction of dust samples, ultra filtration and lyophilisation techniques. • Protein separation techniques (liquid chromatography).• SDS-PAGE and western blotting.• Biotinylation methods for allergenic protein fraction. • Basophile histamin release test in whole blood (collaboration with the Ref. Lab.). • Developed a new Magic Lite specific IgE assay against pine allergens. • Produced allergy extraction of around 100 different samples of mould on wood dust• Prepared crude allergen extracts for skin prick test (for Pharmaceutical preparations).• Ph.D education (finalised 2003).• Designed requisition form for allergy tests and lowered the total number of allergy tests (by 20 %) in the Vestsjælland County, and at the same time elevating the total number of positive IgE test.• Evaluated the quality and assay transfer in Hematology, General Clinical Chemistry and Allergy testing. Show less

Ph.D, Clinical Biochemistry

Activities and Societies: Clinical Biochemistry, (Member of DSKB) Thombosis and Heamostasis (Memeber of DSTH) PhD

Specialist In Clinical Biochemistry, Clinical/Medical Laboratory Science/Research And Allied Professions, Specialist In Clincal Biochemistry

Activities and Societies: Danish Society of Clinical Biochemistry Dansk Selskab for Klinisk Biokemi, (DSKB) Clinical Biochemist (UU-II)

Euroclinchem, European Specialist In Clinical Chemistry And Laboratory Medicine, Euroclinchem (Certified By Ec4)

Activities and Societies: European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) and Danish Society.

Master Of Science, Biochemistry

Activities and Societies: Master thiesis: Identification, purification and characterisation of allergens from the storage mite.