QC Analytical Development Manager – Oral Solid Dosage Forms / Laborleitung analytische Entwicklung (m/w/d)
Core
Lead the analytical development and quality control team for oral solid dosage forms (OSD), managing projects from early development through commercial manufacturing and ensuring GMP compliance.
Role type
Senior IC QC Analytical Development Manager (Oral Solid Dosage Forms)
Builds
Analytical methods, dissolution protocols, and quality control processes for OSD products
Domain
Pharmaceutical manufacturing / Oral Solid Dosage Forms
Required skills
Analytical method development and validation, Dissolution method development, GMP compliance, ICH/FDA/EMA guidelines, HPLC/UHPLC/GC/LC-MS, Stability study design, Impurity profiling, Nitrosamine risk assessment, Elemental Impurities (ICH Q3D), Team leadership, Project management
Preferred skills
Lean Six Sigma Green or Black Belt, CDMO/Contract manufacturing experience, Empower/LIMS software proficiency
Technologies
HPLC, UHPLC, GC, LC-MS, Empower, LIMS
Responsibilities
Lead and develop the analytical development team; Direct QC for GMP batches in formulation development; Develop, optimize, and validate analytical methods for OSDs; Lead dissolution method development and transfer; Manage analytical projects and client communications; Ensure GMP compliance including OOS/OOT handling and CAPA; Oversee stability programs and analytical risk assessments; Collaborate with formulation, manufacturing, and QA teams.
Seniority
Senior, hands-on IC with leadership responsibilities
