Senior Priciple Consultant. Working on a Covid Vaccine during the pandemic, involving transfer of the drug substance manufacturing process to a CMO, GMP manufacturing for clinical trials and process characterisation. Confidential client, 2021 - 2022

Senior Priciple Consultant. Supporting a microbiom project in GMP manufacturing for a phase I clinical study in woman’s health. Tasks include support to production, review of batch records, raw materials selection, authoring regulatory documents for clinical trials applications. Confidential client, 2023 - 2025

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 Principle Consultant. Assisting a vaccine development company on risk assessments for nitrosamines, elemental impurities, residual solvents and E&L. Confidential client, 2025 - 26

Senior Principle Consultant. Supporting development of a vaccine for a microbial target during process transfer and process scaleup for phase III clinical trials. Tasks include characterisation of host cell proteins via ELISA and MS based analysus, troubleshooting the process, raw material qualification, resin reuse studies and E&L risk assessments. Confidential client, 2024 - 2026

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