Frederic Goldschmidt Email & Phone Number

Allschwil, Bâle-Campagne, Suisse

Manager in ADQC (GMP) responsible for management of analytical drug substance project activities for early phase and late phase projects according to cGMP standards representing analytics in technical project team and CMC team including:-Outsourcing of analytical activities to CROs/CMOs-Management of employees and training of laboratory personnel-Development, optimization and validation of analytical methods including writing, review and approval of protocols and reports-Conduction, interpretation and approval of release and retest analysis, stability studies and method transfer-Establishment and writing of specifications for RSM, intermediates and API release. -Management of product or process troubleshooting, investigations, deviations, change requests, CAPA, product complaints and other analytical tasks -Establishment of source documents for IND’s and NDA’s filings-Qualification and management of reference standards-Subject matter expert for LC method development (HPLC/UHPLC), modeling/prediction software e.g Drylab, ACD/Labs and troubleshooting

Allschwil, Basel-Country, Switzerland

Start at Actelion Pharmaceuticals Ltd as Senior lab technician in ADQC (GMP) in 06/2010, promotion to Scientific associate in 01/2012, promotion to Senior scientific associate in 01/2014 responsible for analytical method development and management of project activities according to cGMP including: -ADQC manager Deputy for daily work organization of laboratory activities-Co-operation with internal partners like Process Research for API synthesis optimization and interaction with CMOs and external partners for implementation of analytical methods and outsourcing processes-Development, optimization and application of UHPLC/Fast LC analytical methods for the analysis from Early Phase to Marketed APIs & metabolites-Interpretation, documentation and review of analytical raw data and reports-Writing of analytical methods, CoA, stability protocol and report, analytical method validations and analytical transfer protocols and reports-Support for investigations regarding product quality

Reinach, Basel-Country, Switzerland

Analytical lab technician in drug product development and stability testing-Development, optimization and validation of analytical HPLC methods and dissolution testing for drug product release -Writing and review of quality documents as SOP’s according to cGMP’s-Ensure that lab equipment are calibrated/maintained/qualified and that corresponding documentation complies to cGMP-Conduct Stability studies analysis for drug products

Basel, Switzerland

Analytical lab technicien in process development in the division Plastic additive and Coating Effects-Coordination of analytical testing and identification of priorities of all the test-related tasks with the production.-Products release from the production-Release Analysis using HPLC, GC, TLC, Ion chromatography, DSC, spectrophotometry, titrations-Cooperation with the production to deliver on time reliable analytical results for in-process control tests (IPCs), raw materials and final products-Development and validation of analytical procedures-Maintenance and control of the analytical instruments

Huningue, Grand Est, France

Laboratory technician in the department of research and development for synthesis of pigments and dyes.-Independent development of organic synthesis-Isolation and characterization of the products (HPLC-MS, GC-MS, IR, UV)-Development and optimization of new laboratory procedures

Lutterbach, Grand Est, France

Military service, Brigade territoriale de la Gendarmerie Nationale in Lutterbach-France