Jan-Gunnar Gustafsson

  • B.Sc., M.Sc. Chemistry and Mathematics, from University of Uppsala
  • Executive MBA from The Stockholm School of Economics (Handelshögskolan)
  • Jan Gunnar Gustafsson
    Mobile: + (46) 703 190 585; Email: jan-gunnar.gustafsson@bio-consulting.se   

    • 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 21 publications & 12 posters, 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

    Core Competencies

    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

    Key Achievements related to deliverables across Career Span

    • Key contributor and responsible for for process part in basic engineering studies for new plants, investments in the scale of 1,500,000,000 SEK (€150,000,000)
    • Key contributor for optimization and adapting manufacturing process to fit an existing manufacturing facility and successfully designed a process so one unit operation was less than 24 hours, meaning that manufacturing could be performed 7 days a week, year around

    Career Progression

    Vice President Process Development and Manufacturing 1st January 2010 – Present
    BAAU THERAPEUTICS AB, Uppsala, Sweden

    Biopharmaceuticals, manufacturing and clinical trials company with 15 staff

    • Spearheading Process development and Manufacturing department, managing all activities associated with Active Pharmaceutical Ingredients, with Drug Product produced at Contract Manufacturing Organisation
    • Establishing, managing and overseeing contracts with other manufacturing organisations, securing agreed upon work and serving as liaison between varying facilities
    • Designing facilities, purchasing equipment, managing system for handling of raw material, fulfilling cGMP requirements, and serving as integral part of management team of company
    Key Achievements

    • Effectively transferred laboratory process to industrial manufacturing process in pilot scale, in addition to formulating agreement for production of drug products at separate contract manufacturing organisation
    • Built successful development and manufacturing department within small organisation with limited resources and no experience of pharmaceuticals

    Owner / Consultant 1st of May 2004 – Present
    BIO EVALUATION BO AB, Uppsala, Sweden

    Life sciences consultancy firm, serving customers in pharmaceutical industry

    • Advising and consulting with clients on all aspects of life science research and development, manufacturing / process improvement, characterisation, and regulatory compliance within various, science-driven industries
    • Assisting in marketing and advertising of various aspects of pharmaceuticals and managing all day to day operations of running consulting company, including business development, funding, and relationship management

    Key Achievement

    • Successfully spearheading negotiations and contract review for CMO activities and purchase from CMO / CRO

    Senior Vice President Process Development and Manufacturing 1st of March 2005 – 1st of October 2008
    RESISTENTIA AB, Uppsala, Sweden

    Pharmaceuticals Company with 36 staff

    • Spearheaded 12-person process development department in fermentation, purification and analyses
    • Managed process development within laboratory for assigning products to contract manufacturing operations, negotiating deals, closings and follow-up
    • Managed contract organisation relationships, maintaining quality assurance and adherence to assignment requirements
    • Screened potential contract manufacturers for future work and served as member on strategic management team

    Key Achievements

    • Successfully created API process, drug product manufacturing process and developed stable formulation for drug product as a liquid
    • Effectively authored analytical methods as well as regulatory documents for application for performing clinical trials

    Director, Commercial Development 1st of August 2001 – 30th of May 2004
    BIOVITRUM AB, Stockholm, Sweden

    Pharmaceutical manufacturing company created from Pharmacia’s Stockholm site

    • Spearheaded commercialising team, many of whom were in research and development and performed calculation for recourses, timeline development, and review of competence to perform requested work
    • Managed process development and manufacturing according to customer requirements for assignments
    • Performed road shows, marketing and selling services to various clienteles and developed promotional material and developed evaluation system that was cost effective

    Key Achievement

    • Successfully led creation of ballpark proposal to start negotiations and deal closer. It was crucial for the Biovitrum further development

    Educational Qualifications

    • 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

    Professional Development

    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

    Professional Affiliations

    • Society for General Microbiology, United Kingdom and Society for Biochemistry, United Kingdom

    Personal Details

    Date of Birth: 20th October, 1950; Nationality: Swedish; Marital Status: Married; Driving License: Swedish driver’s license; Languages: Fluent in Swedish and English
    References available upon request
  • Member of the board  for CEFFORT, was member of the board for CBioSep, the Swedish Competence Center for BioSeparation, Lund.

Jan-Gunnar Gustafsson

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