Experience

Cobo Technologies - CRISPR INDEL Profiling Platform

• Chairman of the board, Investor and co-owner

  • Jul 2018 - Present

  Copenhagen Area, Denmark a Biomedical Research and Drug Discovery Company - CRISPR/Cas9 INDEL Profiling Platform - Genome Editing Tools and Services - and other services



rightQA.dk

• Denmark
• Pharmaceutical Manufacturing

• Senior Consultant & Owner

  • 2016 - Present

  Denmark “-consultant with strategic view” Practical solutions - quality tasks and consulting We take responsibility and get things done We offer practical solutions that works! Audits & Due Diligences Authority inspections e.g. FDA & EU Professional advice / second opinion about Quality cases & Risk evaluations Quality agreements Solutions in the intersection between Quality, CMC and Regulatory Quality metrics Quality Management Reviews & Product Reviews Improve all… Show more “-consultant with strategic view” Practical solutions - quality tasks and consulting We take responsibility and get things done We offer practical solutions that works! Audits & Due Diligences Authority inspections e.g. FDA & EU Professional advice / second opinion about Quality cases & Risk evaluations Quality agreements Solutions in the intersection between Quality, CMC and Regulatory Quality metrics Quality Management Reviews & Product Reviews Improve all types of Quality systems to be more efficient Coordination of validation and implementation of IT-systems Develop your Quality Organizations to be more efficient Effective LEAN in Quality - that works Show less



LEO Pharma

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Corporate Vice President - Global Quality & Environment, Health and Safety

  • 2007 - 2016

  Top Global Quality Officer in LEO Pharma Reporting to the president, CEO 2007-2008 Reporting to Executive/Senior Vice President of Global Product Supply 2008-2016 RESPONSIBILITIES: Overall for Quality in LEO globally: GMP GCP GLP GDP Release of products and IMP QA for Pharmavigilance Environment, Health and Safety Quality systems and IT systems Total 186 employees in 6 countries Budget of 20 mio. € ACHIEVEMENTS: Transformed global quality systems (Quality-manual, policies… Show more Reporting to the president, CEO 2007-2008 Reporting to Executive/Senior Vice President of Global Product Supply 2008-2016 RESPONSIBILITIES: Overall for Quality in LEO globally: GMP GCP GLP GDP Release of products and IMP QA for Pharmavigilance Environment, Health and Safety Quality systems and IT systems Total 186 employees in 6 countries Budget of 20 mio. € ACHIEVEMENTS: Transformed global quality systems (Quality-manual, policies, SOP-system, deviations, recurring deviations, audits, change controls, customer complaints, GCP set-up, validations etc.) into more modern levels - with a pragmatic low cost attitude Implemented quality IT-systems (document handling system & system for quality processes) to become more effective and to support the business Introduced Quality Metric globally which gave much better management overview of the compliance status of the entire company Introduced LEAN in Quality globally which resulted in a more efficient quality organization Introduced Quality Management Reviews according to EU legislation. This gave top management a much better tool for high level decisions Built up an ISO system as Medical Devices were introduced in LEO. ISO certification achieved so LEO could go into the medical devices business A number of comprehensive reorganizations that resulted in a more agile and efficient Quality organization with stakeholder orientation Run a global company-wide compliance programme of 150 mio € during a number of years to upgrade facilities, systems and documentation to ensure that quality compliance was up to date Ensured the LEO Group globally was transformed from a critical compliance level to a compliance level with no major troubles with authorities Participated in several filings and succesful launches of new products - e.g.: - An actinic keratosis product - Transformation of an acquired development company to a commercial company - A psoriasis foam produced at a CMO in Germany - An applicator product (psoriasis)

• Director of Quality Assurance - compliance, validation & implementation IT-systems, rics evaluations

  • 2003 - 2007

  Reporting to the president CEO RESPONSIBILITIES: Overall responsible for Quality (GMP & GDP) in Denmark and globally for GCP, GLP & QA for Pharmacovigilance Quality systems and IT systems The global quality corporation in LEO Group ACHIEVEMENTS: Transformed a very conservative and fragmented quality organization into a global very connected quality organization Ensured that the company did not come into troubles with the authorities despite a low compliance level Built up quality systems to… Show more RESPONSIBILITIES: Overall responsible for Quality (GMP & GDP) in Denmark and globally for GCP, GLP & QA for Pharmacovigilance Quality systems and IT systems The global quality corporation in LEO Group ACHIEVEMENTS: Transformed a very conservative and fragmented quality organization into a global very connected quality organization Ensured that the company did not come into troubles with the authorities despite a low compliance level Built up quality systems to efficient support the business processes of the company



Leukotech - a biotech start-up

• Technical Development Director and Quality Director - practical solutions for small biotech

  • 2001 - 2003

  Copenhagen Area, Capital Region, Denmark RESPONSIBILITIES: Took care of all internal activities in the company: Cell culture Sterile Technology Protein purification Product development & formulation Chemical and microbiological analyses Quality Contract research & production ACHIEVEMENTS: Statement: “It is amazing what you can achieve with only 8 staff in 2 years”: Set up sterile cell culture production of 100 mg protein/day in hollow fiber technology with continous harvest Have put a clean… Show more RESPONSIBILITIES: Took care of all internal activities in the company: Cell culture Sterile Technology Protein purification Product development & formulation Chemical and microbiological analyses Quality Contract research & production ACHIEVEMENTS: Statement: “It is amazing what you can achieve with only 8 staff in 2 years”: Set up sterile cell culture production of 100 mg protein/day in hollow fiber technology with continous harvest Have put a clean room in successful operation with utilities and sterile procedures in a very short time Implemented a complete environmental monitoring program Established a highly productive Master Cell Bank Set-up of a full blown Down Stream Process of purification of the harvested protein with 4 filters, an- and cat-ion exchange, gel filtration chromatography and virus filtration Set up of a complete analysis programme: HBP-ELISA, IL-6 ELISA, SDS-PAGE (PHAST), IEF, Glucose & lactate determination, UV-measurement Developed a smart and cheap GMP-system in preparation for inspection to obtain a production license for bulk for clinical trials. Prepared a complete toxicological programme including GLP Examined the entire development process concerning regulatory and agency requirements Show less



Novo Nordisk

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Various positions as Department Manager, Group Head, Section Head, Scientist, Chemist

  • 1983 - 2001

  Analytical chemistry, protein chemistry, development, quality, management RESPONSIBILITIES: Management of a department of 69 employees Analytical chemistry: - GMP-analysis of finished products in development, stability studies, release of production and costumer compliance - GLP-analysis of animal studies - Broad range of laboratory techniques - 50 different methods of analysis - 75 pieces of laboratory equipment - Protein chemistry Insulin range - Growth Hormone - Heparin ACHIEVEMENTS: Participated in a number of development… Show more RESPONSIBILITIES: Management of a department of 69 employees Analytical chemistry: - GMP-analysis of finished products in development, stability studies, release of production and costumer compliance - GLP-analysis of animal studies - Broad range of laboratory techniques - 50 different methods of analysis - 75 pieces of laboratory equipment - Protein chemistry Insulin range - Growth Hormone - Heparin ACHIEVEMENTS: Participated in a number of development projects which resulted in some of today succesfull products of Novo Nordisk: - Task of new insulin analogues in phase 1, 2 and most 3. - Different formulations of diabetes products - Numerous quantity of regulatory documents for INDs (Investigational News Drugs) and NDAs (New - Drug Applications) worked out - Filings and successfully launches of new products Significantly increased the quality level in laboratories: - Took initiative to a lot af changes and new set-ups - A lot of validations and qualifications implemented and carried out which significantly increased the compliance level - Intensive experience with inspections from different authorities. The department is one of the mostly inspected departments at Novo Nordisk Show less