25.03.2026 aktualisiert
100 % verfügbar
Senior Analytical & CMC Project Leader - Pharmaceutical Sciences
Grenzach-Wyhlen, Deutschland
Weltweit
Dipl.-Ing. Biological ChemistryÜber mich
Senior Pharma & Operations Expert, 18+ years in Big Pharma, CDMOs & GMP environments (CH/DE). Lean Six Sigma Black Belt. SME in Analytical Sciences, CMC, QC, method transfer, CAPA & deviation management. Cross-functional leadership across QA, QC, Manufacturing & Regulatory. DE/EN/FR fluent.
Skills
ForschungChromatographieAPIsAnalytische VerfahrenData AnalysisBiopharmazeutikaBotulinumtoxinGood Manufacturing PracticesKorrektur- und VorbeugemaßnahmeVermarktungDatensystemeGas-Chromatographie und MassenspektrometrieProjektmanagementMinitabMultidisziplinären Ansatz
Analytical Development Strategy
Expertise in defining and executing analytical development strategies for pharmaceutical products in GMP-regulated environments, including method transfer and validation across early clinical development to commercialization phases.
CMC Regulatory Support
Comprehensive knowledge of CMC regulatory documentation, compliance with GMP, cGMP, BPF standards, and support for health authority inspections and OOS/OOT investigations.
Cross-functional Project Leadership
Proven ability to lead multidisciplinary teams across QA, QC, API production, and logistics while managing risk-based assessments and decision-making processes in matrix organizations.
Analytical Method Development
Advanced skills in HPLC/UPLC, LC-MS/MS, QToF, GC-MS techniques for method development, optimization and validation of pharmaceutical compounds.
Quality Management Systems
Implementation of Analytical Quality by Design principles, CAPA optimization, deviation management, and performance KPI monitoring.
Pharmaceutical Formulations
Specialized knowledge in peptides, injectables, oral solid dosage forms, and biologics manufacturing processes.
Statistical Analysis Tools
Proficiency in Minitab for statistical evaluation and data analysis in pharmaceutical development contexts.
Chromatography Data Systems
Expertise with CDS platforms including Analyst, MassHunter, ChemStation, Chromeleon, and Xcalibur for analytical data management.
Expertise in defining and executing analytical development strategies for pharmaceutical products in GMP-regulated environments, including method transfer and validation across early clinical development to commercialization phases.
CMC Regulatory Support
Comprehensive knowledge of CMC regulatory documentation, compliance with GMP, cGMP, BPF standards, and support for health authority inspections and OOS/OOT investigations.
Cross-functional Project Leadership
Proven ability to lead multidisciplinary teams across QA, QC, API production, and logistics while managing risk-based assessments and decision-making processes in matrix organizations.
Analytical Method Development
Advanced skills in HPLC/UPLC, LC-MS/MS, QToF, GC-MS techniques for method development, optimization and validation of pharmaceutical compounds.
Quality Management Systems
Implementation of Analytical Quality by Design principles, CAPA optimization, deviation management, and performance KPI monitoring.
Pharmaceutical Formulations
Specialized knowledge in peptides, injectables, oral solid dosage forms, and biologics manufacturing processes.
Statistical Analysis Tools
Proficiency in Minitab for statistical evaluation and data analysis in pharmaceutical development contexts.
Chromatography Data Systems
Expertise with CDS platforms including Analyst, MassHunter, ChemStation, Chromeleon, and Xcalibur for analytical data management.
Sprachen
DeutschverhandlungssicherEnglischverhandlungssicherFranzösischMuttersprache
Projekthistorie
Senior analytical and CMC authority supporting product development, industrialization, and lifecycle management within a GMP environment. Leading analytical development strategies, method transfers, and validation support while acting as global Analytical SME for internal sites and external CRO/CDMO partners.
Led cross-functional transformation initiatives in a GMP biologics manufacturing environment. Managed multidisciplinary teams across QA, QC, API production, fill & finish, and logistics while acting as Quality SME supporting deviation management and CAPA optimization.
Performed GMP gap analyses, inspection readiness, and risk assessments for pharmaceutical clients including SANOFI and CORDEN PHARMA. Supported OOS/OOT investigations, CAPA strategies, and SOP authoring.