• Versatile and highly accomplished Senior Executive Management Professional offering over 30 years’ experience in the areas of Process Development, Strategic Planning, Creative Solution Development, Manufacturing, Organizational Health & Safety Management, Contract Negotiation, Quality Assurance and Project Management in the Pharmaceutical industry
• Biopharmaceutical Expert, Scientist and a Strategic Business Development Manager with extensive leadership & management skills and rich exposure to Swedish, American and European markets
• Regulatory expertise. Is a core knowledge based on 21 years of formal, theoretical and practical know how of biopharmaceutical requirements. Have been responsible for fulfilling regulatory requirement during development phases and manufacturing for clinical trials and commercial manufacturing, including cGMP regulation rules, also Quality Assurance. Responsible for setting up specifications for in-process, API and DP, adapted to requirements for phase I – IV. Have written the CMC part in IND, NDA, BLA, EMEA and IMPD applications for clinical trials, also DMF, Drug Master File. Taking part in pre-meeting with FDA Have a good understand of present branch requirements for biopharmaceuticals, regarding regulatory, cGMP, documentation and registration requirements
• Published author with over 30 publications, in addition to securing 2 United States patents and recognized as an invited speaker in international meetings on bio / pharmaceutical, analytical, manufacturing, especially in the use of CMO, Contract Research Organizations
• Skilled in leading Process Transformations and Enhancement and utilizing Business Intellect, Strategic Insight and Sharp Planning Skills to manage Manufacturing Operations and meet top line and bottom line objectives
• Proficient understanding of market research, marketing strategies, and development of promotion material and expert in impacting corporate financial performance through skilful development, enhancement and orchestration of high level projects for top tier biotechnology companies
• Outstanding track record serving organisations of high market repute like Pharmacia & Resistentia in critical positions
• Recognized for hands-on experience in leading organisations through process enhancement initiatives and with vast experience focused on strategic planning and creative solution development
• Implementing and executing successful strategies leading to effective operational excellence and improved work ethic, culture & performance
• An excellent communicator fluent in Swedish & English and a top negotiator successfully negotiating CMO terms and conditions, as well as managing CMO activities throughout lifecycle with the ability to work under pressure in fast-paced, time sensitive environments. Proven ability to interact effectively with people of diverse nationalities and comfortable working in a multi-cultural set-up
Process Design & Development, Biopharmaceutical Research, Business Development, QbD (Quality by Design) & PAT, Strategy Planning / Implementation, API & DP Specification Set-Up, Change Management, Green Field Operations, Account Management, Crisis Management, Operational Efficiency & Resource Optimization, SOP including GMP / GLP, Documentation Control, Budget Management, Quality & Safety Management, Performance Monitoring / Enhancement, Due Diligence & Client Relationship Management
Owner / Consultant 1st of May 2004 – Present
BIO EVALUATION BO AB, Uppsala, Sweden
Life sciences consultancy firm, serving customers in pharmaceutical industry
Vice President Process Development and Manufacturing 1st January 2010 – 31st December 2011
BAAU THERAPEUTICS AB, Uppsala, Sweden
Senior Vice President Process Development and Manufacturing 1st of March 2005 – 1st of October 2008
RESISTENTIA AB, Uppsala, Sweden
Director, Commercial Development 1st of August 2001 – 30th of May 2004
BIOVITRUM AB, Stockholm, Sweden
PHARMACIA AB et.al, Uppsala and Stockholm 1st of December 1978 – 30th of July 2001
• Master of Business Administration, Business Development and Information Technology
1st of October 2003 – 1st of September 2005
Stockholm School of Economics (Handelshögskolan), Stockholm, Sweden
• Master of Science 1st of September 1977 – 30th of October 1978
Uppsala University, Uppsala, Sweden
• Bachelor of Science 1st of September 1973 – 30th of May 1977
Uppsala University, Uppsala, Sweden
Strategic Alliances within Biotech / Pharmaceuticals, Registration of Pharmaceuticals in Europe, Strategic Research and Development of Biotechnology companies, Key Account Management, Current Good Manufacturing Practice and Compliance with U.S. FDA Requirements, Project Management, Effective Project Management, Kunna och Våga leda project, Regulation of Biologics, CEBER Policies and Expectations, Production, English, Strategies for Meeting FDA Requirements for Biotechnology Derived Products
Was member of the board for the teen year project; CBioSep, the Swedish Center for Bio Separation in Lund, is member of the board for CEFFORT, Sweden.
Date of Birth: 20th October, 1950; Nationality: Swedish; Languages: Fluent in Swedish and English
Professor, Dept of Soil Sciences, SLU, since 2000
Master´s degree in Agricultural Sciences SLU 1979
Doctor of Agriculture, specialisation in Microbiology, SLU 1985
Associate Professor in Plant Nutrition (‘Docent i växtnäringslära’) SLU 1991
Academic duties, recent years
• Member of examination board on several occasions in SLU and externally.
• Appointed expert for scrutiny of applications for INCO-COPERNICUS, National Environment Research Council, Swindon, UK, Norwegian Research Council, Quality of Life Programme, 5th Framework, Estonian Research Board.
• Scientific editor, Acta Agriculturae Scandinavica section B since 2002
• Referee of Canadian Journal of Botany, Soil Biology and Biochemistry, Applied Soil Ecology, Environmental Pollution, Mycorrhiza, Plant and Soil.
• Swedish delegate and member of the Management Committee of COST action 8.21 Arbuscular mycorrhizae in sustainable soil-plant systems, 1994-1998; Cost Action 8.38 Managing arbuscular mycorrhizal fungi for improving the quality and plant health in agriculture, 1999-2005; COST action 8.58 Viticulture: biotic and abioitc stress grapevine defence mechanism and grape development, 2005-
Ph. D. students being tutored
Finalized five PhD students.
Publised over 100 international publications reviewed by referees.
Date of Birth: 2th September, 1955; Nationality: Swedish; Languages: Fluent in Swedish and English