Core Competences
20 years of experience in the pharmaceutical industry
Working within both R&D, production support and manufacturing development
Experience with anything from production of milligram of API for clinical trials, to production of tons enzymes/antibiotics for the food/ Pharma industry
Core competences are within purification of API, including risk assessments, process development and validation, manufacturing support to the production, complex non conformities, pilot scale productions, regulatory documents etc.
Selected Project Experience
Senior Consultant. Process Transfers from one CMO (a contract manufacture) to another. Supporting a company in the process of transferring a manufacturing process from one CMO to another CMO for the purpose of upscaling the process. The tasks included gathering historical data, preparing bill of materials, block flow diagrams and identifying opportunities for process optimisations. Confidential Client, 2019-2020
Senior Consultant. Preparation for PPQ for a Biological API. Supporting a project group in the preparations for PPQ for a Biological API at a CMO. The tasks included reviewing documentation from the CMO like process risk assessments, control strategies, polymer risk assessment, laboratory characterisation protocols and reports. Confidential Client, 2018-2020
Senior Consultant. Evaluation of UFDF Solutions. Helping a company evaluating different solutions for a UFDF process step intended to be implemented in a new greenfield facility. The proposed solutions included normal cassette format, spiral format and ceramic filters. Pilot scale tests were conducted in collaboration with the different vendors (Sartorius, Alfa Laval and Pall) and the results were evaluated together with the rest of the project group. A solution was selected that optimizing the process performance and at the same time reduced the investment cost significantly. Confidential Client, 2017-2018
Senior Consultant. Introduction of PAT Technology. Supporting a project group working on implementing PAT technology in an existing API facility. The tasks included facilitation of risk assessments, writing URSes, reviewing P&IDs and writing test plans. The PAT technologies implemented included pH, oxygen, refractive index, radar (level) and particle size distribution size measurement. Confidential Client, 2017 - 2018
Senior Consultant. Greenfield API Production Facility in USA. Supporting the project during Basic Design, authoring/ approving documents like Quality Risk Assessments (QRM), Requirement Risk Assessments (RRA), User Requirement Specifications (URS), Technical Specifications (TS), Process Flow Diagrams (PFD), Piping & Instrumentation Diagrams (P&IDs) and Functional Specifications (FS). Organized a C-type meeting with FDA and author/ main presenter at a meeting with DMA (Danish Medical Agency). Confidential Client, 2015-2016
Senior Consultant. Greenfield API Production Facility in Denmark. Supporting the project during Basic Design, authoring/ approving documents like Failuremode and effects analysis (FMEA), Product Protection Control Strategy (PPCS), Media Code list, QRMs, RRAs, URSs, TSs, PFDs, P&IDs and FSs. Confidential Client, 2014-2015
Timeline
Senior Consultant at Harper and Vedel 2016 - Free lancer on a project to project basis 2016 – Current
Senior Consultant, Greenfield API Facilities in DK and USA Pharmasphere Consulting 2014 – 2016
Senior Scientist, Dept. 1364: Protein Purification Technology, Novo Nordisk A/S 2013 – 2014
Promoted to “Area Specialist within Purification” at Novo Nordisk A/S, 2013
Senior Scientist, Dept. 1294: DAPI Process Support, Novo Nordisk A/S 2011-2013
Project Manager, DICOB 3 Star Project (1/2 year) in Dept. 1819/2299, Novo Nordisk A/S 2010
Development Scientist, Dept. 1294: DAPI Process Support, Novo Nordisk A/S 2007-2010
Chemist/ Project Manager, Dept. 003: Trypsine Extraction, Novo Nordisk A/S 2005-2006
Research Scientist, Manufacturing Development, Pharmexa A/S 2004-2005
Master Thesis, Biochemistry, University of Copenhagen/ Pharmexa A/S 2002-2004