Process Development Technician
Current• Develop manufacturing processes for sterile pharmaceutical products (cGMP compliant)• Design of experiments according to Quality by Design (QbD, ICH Q2) framework, and their respective statistical analysis• Coordinate within teams the day-to-day administrative and shop floor operations (Six Sigma Green Belt, Lean & 5S compliant)• Monitor quality compliance as per ISO 9001/31000/14000, as well as ICH Q series for pharm dev.• Manage employees (up to 4 direct report lines) using situational leadership framework• Manage documentation (SOPs, H&S clearances, PFMEAs, CAPAs, ALCOA+, technical reports & others)• Manage shop floor supply chain using SAP tools, interacting with internal & external stakeholders• Complied with analytical method development & validation (ICH-QSEM series/ASTM-compliant)• Train employees and manage their training routines