Frankfurt, Hesse, Germany
- PhD in chemistry with the focus on analytical chemistry - Experience in the pharmaceutical industry working in the departments quality control (QC) and quality assurance (QA) (in GMP regulated environment) - Experience in analytical laboratories of different sectors such as industry (Celanese & pharmaceutical companies), a government agency (Federal Criminal Police Office) and research institutes (e.g. Max Planck Institute for Chemistry) - Experience in the aseptic filling process of pharmaceuticals - Experience in leading projects in the quality control department and in research (trace analysis) - Expert in the development and validation of analytical methods - Managed an analytical laboratory - Former head of the sustainability group at the Max Planck Institute for Chemistry
- Part of the Quality QC Analytical expertise and transfer team - Project lead for QC topics for production at external site (QC strategy, quality agreements, sampling strategy, sampling justification protocol, shipment, stability studies etc.)
Senior Scientist at CSL Behring in the group „Quality Control Analytical Technology“ responsible for method transfers, development, verifications and validations. Tasks: - Project Lead for the transfer of all analytical methods for product release testing of two products to an external testing laboratory in an Asian country --> Project management --> Troubleshooting --> Cooperation between lab personal in Marburg and analysts from external company --> Successful transfer of one product with 25 methods within only 4 months --> On-site suppport (inter-cultural exchange) - Subject matter expert of different analytical methods (chromatography methods, density determination, conductivity determination) - Expert for analytical methods in deviations and change controls - Support of submission of new analytical method and specification setting (response to health authority questions and requests) - Preparing and representing method validations/verifications in inspections and audits - Part of project team for pipetting robot - Review of method validations
Task as "QA manager" at Sanofi in Frankfurt in the group „quality“ of the production unit fill & finish (since 01.09.2024): - Theoretical and practical trainings: GMP, aseptic processes, work in clean room environment, processes of filling line, contamination control strategy (CCS) - Member of the extended leadership team - Updating of revalidation plans for aseptic process simulation (sterile media fill) according to regulations of annex 1 of EU GMP guideline - Supervision of aseptic process simulation (media fill) - Revalidation report - Updating of master batch manufacturing record (MBMR) - Revision of requalification report of devices - Working on deviations (action team meeting, immediate action, root cause analysis, CAPAs, support of batch assessment) - Risk assessments - Writing of plan for flow visualisation in isolator and observation of the flow visualisation (smoke study) - Preparation of inspections - Updating site validation master plan
Task in inter-project phase at agap2 (01.08.2024-31.08.2024): - Presentation of the former project - Continuous further education (quality assurance, CAPA, aseptic production, media fills, new regulations of annex 1 of the EU GMP guidelines) - Internal projects (improvement of the onboarding process, structuring of new sharepoint and knowledge database) Task as "Scientist" at CSL Behring in Marburg in the group Quality Control Analytical Technology (13.02.2023 - 31.07.2024): - Project lead of the implementation and validation of a size exclusion HPLC (SE-HPLC) method for the quantification of impurities in a drug (protein) using a fluorescence detector (FLD) - Lead of additional studies as support for the specification setting for the new method - Training of colleagues - Troubleshooting and root cause analysis for HPLC methods - Subject Matter Expert (SME) for the transfer of an SEC method to other sites (globally) - Support as SME and temporary management of the method transfer of two RP-HPLC methods - Project management of the outsourcing of a Ph. Eur. method to an external test laboratory (titration after enzymatic degradation) - Support of different issues in a GMP-certified analytical laboratory - Review of method validations
Task as "Scientist" at CSL Behring in Marburg in the group Quality Control Analytical Technology (since 13.02.2023): - Method development and validation of a size exclusion HPLC (SEC) method for the quantification of impurities in protein samples using a fluorescence detector (FLD) - Support of method transfer to other sites as subject matter expert (different RP-HPLC methods) - Troubleshooting on HPLC methods (root cause analysis) - Project lead for implementing new method (titration after enzyme degradation) for substitution of an existing method (discussion and decision about outsourcing of the method) - Various other projects in a GMP-certified analytical laboratory (electroimmunodiffusion according to Laurell) Tasks during onboarding at agap2 (16.01.-12.02.2023): - Internal workshops and training courses - Continuous independent further education (quality management and assurance, GxP, CAPA) - Support in the process of recruiting (active sourcing to identify professionals on social media platforms, selection of candidates) - Internal projects
- Management of the analytical laboratory and supervision of students - Derivatization of quinones for analysis by GC-MS - Finalizing projects started during the phD
- Management of the analytical laboratory including topics such as occupational and environmental safety, ordering of equipment, the creation of operating instructions and standard operating procedures (SOPs) - Supervision of students - Sample preparation (extraction, purification) and analysis using GC-MS - Investigation of toxicity using various assays - Supervision of Bachelor thesis analyzing quinones and hydroxylated PAHs using GC-MS and LC-MS
At One.Analytics: Continuation of the topic of the master thesis
At One.Analytics: Project title: "Development and Validation of a Headspace Gas Chromatography Method for the Determination of Residual Monomers in Polyoxymethylene"
At One.Analytics: - Validation of a new test method - Implementation of a new chromatography software (Chromeleon) - Updating of SOPs and operating instructions