Experience

Toxicology Knowledge Team Sweden AB

• Sweden
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Consultant

  • Sep 2012 - Present

  Co-founder of Toxicology Knowledge Team Sweden AB (TKT), a consultancy firm of former AstraZeneca toxicologists. TKT provides toxicological consultancy services in pharmaceutical development, chemical risk assessment and medical devices. For more details, please visit www.tktsweden.com.Responsible Investigator for >250 scientific reports for TKT customers, including - Occupational Exposure Limit (OEL) determinations- Mutagenic impurities assessment reports (ICH M7 compliant) - Chemical safety assessments- Drug product safety statements- Food additive safety evaluations- Permitted Daily Exposure Reports - Elemental impurities (ICH Q3D)- Extractables and Leachables



AstraZeneca R&D

• Principal Scientist

  • Apr 2010 - Nov 2012

  - Provider of toxicological advice and guidance on risk assessment of impurities in drug substances and products including organic/inorganic impurities, solvents, metals, leechables/extractables and genotoxic impurities in order to meet regulatory demands - Interpretation of SAR analyses (e.g. DEREK, CASE) and identification of potential risks associated with chemical structure(s) of lead series in early drug discovery-Regular contribution to several therapy areas (both Discovery and Development projects) by literature reviews and safety assessment reports- Responsible for problem-solving activities within genetic toxicology including regulatory interactions- Member of Preclinical Safety Science Group with the remit of target safety evaluation as well as coordination of predictive safety and in vivo toxicology work to assess evolving chemical series and candidate drugs.- Project leader for external collaboration with Stockholm University with the aim to develop novel tools for problem solving activities within genetic toxicology- Extensive pedagogical experience, supervising several PhD and MSc students in the fields of genetic toxicology and radiobiology; regularly lecturing at various graduate courses

• Study Director

  • Aug 2003 - Nov 2012

  • Extensive support of AZ discovery and development projects with in vivo and in vitro Comet assay studies. Delivered >30 Comet studies on AZ substances• Validation of experimental protocols for the Comet assay in various organs and in vitro cell models• Development and validation of Comet screen and combined Micronucleus/Comet screen methods with low compound requirement• GLP validation of rat liver Comet assay• Local System Owner for a GLP computerized system (Comet IV)



Stockholm University

• Sweden
• Research Services
• 700 & Above Employee

• Senior Research Scientist

  • Jan 1999 - Jul 2003

  Dept. of Genetic and Cellular ToxicologyEU FP5: Mechanisms of formation of ionizing radiation induced chromosomal aberrations: Impact of repair pathways and nuclear architecture. Nuclear Energy 1998-2002. Contract nr. FIS5-1999- 00071• Co-principal Investigator in the workpackage “Analysis of chromosomal damage in apoptotic and viable cells”. Dept. of Genetic and Cellular ToxicologyEU FP5: Mechanisms of formation of ionizing radiation induced chromosomal aberrations: Impact of repair pathways and nuclear architecture. Nuclear Energy 1998-2002. Contract nr. FIS5-1999- 00071• Co-principal Investigator in the workpackage “Analysis of chromosomal damage in apoptotic and viable cells”.



Swedish Radiation Protection Authority

• Research Scientist

  • Jan 1998 - Dec 1998

  Evaluation of radiation-induced biomarkers for the detection and assessment of absorbed radiation doses Evaluation of radiation-induced biomarkers for the detection and assessment of absorbed radiation doses



Stockholm University

• Sweden
• Research Services
• 700 & Above Employee

• Research Scientist

  • Jan 1997 - Dec 1997

  Dept. of Molecular Genome ResearchEU FP4: Chromatin structure and DNA repair in relation to ionizing radiation induced chromosomal aberrations in mammalian cells. Contract nr. FI4PCT950001, 1996-1999.• Co-principal Investigator in the workpackage “The role of the apoptotic process for the expression of chromosomal aberrations"

• Postdoctoral Fellow

  • Oct 1992 - Dec 1996

  Dept.of RadiobiologyStudies on radiation-induced DNA damage and repair in eukaryotic cells, development of novel methods for detection of oxidative DNA damage using DNA repair enzymes