Experience

SANI Membranes

• Denmark
• Mechanical Or Industrial Engineering
• 1 - 100 Employee

• Pharma Business Development Director

  • Mar 2023 - Present



LEO Pharma

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director/Head of Global MSAT Biologics Drug Substances

  • May 2021 - Mar 2023

  - Manage the newly established Global MSAT Biologics Drug Substances covering 3 areas: upstream & downstream processes, engineering/support to production/CMO- Member of Global MSAT Leadership Team (Denmark, Ireland, France, Italy): define global strategy- Establish plan & strategy for implementing new global MSAT activities within mono-/multi-specifics antibodies: resources, facility, budget, CMO- Results on significant yield increase on exciting products- Support 200 Mio€ capital investment- Ensure deliveries in time with adequate quality- change culture in reporting data and working across LEO Pharma- Investment management to implement state-of-the-art technologies- Increase laboratories capacity and hiring high qualified resources Show less

• Head of MSAT API Process

  • Jan 2019 - Apr 2021

  - Manage the MSAT API Process department covering 3 areas: upstream & downstream processes, engineering/support to production- Results on significant yield increase on exciting products- Support 200 Mio€ capital investment - Ensure deliveries in time with adequate quality- change culture in reporting data and working across LEO Pharma- Investment management to implement state-of-the-art technologies - Increase laboratories capacity and hiring high qualified resources



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director/Head of Upstream Biopharmaceutical Process Development

  • Dec 2016 - Jan 2019

  - Substitute of Head Bioprocess Development during maternity leave: responsible of 5 departments, 80 employees, integrated to Leadership Team of Head of Biopharmaceutics Development France, strategy meeting, budget & resources planning - Manage the upstream process development group, 3 teams, 30 employees: resource planning, talent recruitment and retainment, project management, technology platform development and operation efficiency improvement (LEAN), equipment investment plan. - Provide strategic, technical, and managerial guidance to group members and technology skill centers across sites: Ensure upstream technical delivery to support product development advancement, develop innovative upstream process technology to improve upstream process productivity and operation efficiency, automation, digitalization - Support Biopharmaceutical process development from early stage to late stage projects (from cell line selection to process characterization and validation) - global USP harmonization lead: responsible for harmonization between Boston, Frankfurt and Paris sites, coordination, define strategy, plan, timelines and delivery - Active member of ECI organisation: Poster chairman at Integrated Continuous Biomanufacturing (ICB), participation at ICB and Cell Culture Engineering events Show less



Novo Nordisk

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Principal scientist and Technology project manager

  • Nov 2003 - Nov 2016

  Responsabilities: - Daily management of several technicians and occasionelly GMP pilot/production plant fermentation teams both in DK and USA, - Member of CMC-technology board, - Member of medium strategy board, - Member of CMC single-use technology board, - Project manager for ATF perfusion process across Novo Nordisk, - Project manager for in-house fed-batch feeds medium development, - Project manager for Single Use Bioreactor. lab & pilot scale. - Budget of 2MioDKK/year & purchase negociations (saving 8 MioDKK) - New patented manufacturing process from lab to GMP production scale, Scientific achievments: - New technologies implementation (ATF, Single Use Bioreactor, online biomass & CO2) at lab-scale and transfer to largest 5000L GMP production scale in DK and USA, - Implementation of 14ml to 1000L Single Use Bioreactor - Design & Implementation of fully customised lab setup - Upstream process transfer and support to the production plant for phase III GMP production (6-25 fold yield increase), - Cell lines (CHO-K1/-DUXX/-GS, hybridoma, HEK293) and fermentation process development (mAb/haemophilia, fed-batch/ perfusion, …), - Implement continuous Z1 purification step in upstream department - Initiate stem cells 3D cultures, - Implementation and development of the newly-built ‘state-of-the-art’ facility at Måløv site, - Responsible of amino acid HPLC unit, hollow fiber system and Cellmate robot (roller bottle) in Biopharm Research Unit (BRU), - Teaching microbial staff of CMC organisation to mammalian cell culture, - Writing parts of documents to authorities for clinical trials, Coordination roles: - Support QA department in auditing GMP external partner (CMO) for GMP phase I-III production, - Department and various pre-clinical projects activities coordination, - Coordination of cross-functional and CMO activities for phase I-III project, Show less



maxygen

• scientist

  • Jun 2002 - Nov 2003

   Phase I project core-team member: - Responsible for planning and coordinating various tasks in molecular biology and protein production departments, - Tasks planning & contact with CMO facility,  Cell lines adaptation to serum free medium,  Serum-free subcloning,  Cell line screening,  Cell bank,  Fermentation process development,  Implementation of new culture conditions,  Development of the fermentation facilities,  Reports and presentation of the results to colleagues and partners. Show less



DTU - Technical University of Denmark

• Denmark
• Research Services
• 700 & Above Employee

• Ph-D

  • Oct 1998 - Dec 2001

  - Industrial Ph.D. thesis in Center of Process Biotechnology at Technical University of Denmark, Lyngby, Denmark in close collaboration with DSM, Delft, The Netherlands : physiological characterisation of a novel fermentative bioprocess leading to adipoyl-7-ADCA by recombinant Penicillium chrysogenum strains expressing the expandase gene of Streptomyces clavuligerus.  Physiological characterisation during batch cultivations,  Correlation between the specific growth rate and the specific productivity during chemostat cultivations,  Determination of limiting steps of the new pathway,  Flux distribution through the pathway,  Determination of inhibition on a key enzyme by the main by-product,  Identification of the main by-product combining HPLC and LC-MS/MS data,  Influence of the cultivations conditions on the ad-7-ADCA pathway,  Degradation of the side chain precursor during cultivations,  Instability of products and by-products,  Morphological investigations,  Optimisation of the HPLC method analysing products and by-products,  Optimisation of the all fermentation process,  Setting-up the automatic ABC’s system taking free-cell samples. Show less