Simon Scholte Email & Phone Number

Pharmaceutical Executive with a demonstrated history leading and managing Engineering, Operations, and various other commercial manufacturing functions in delivering value to clients and enhancing patients lives. Experience in multi-site management, expansion, leveraging and expanding capabilities, and putting process in place for sustainable execution. Prior experience at SME level in managing Validation processes (PQLI, V&V, C&Q, etc), GXP - Good Manufacturing Practices (GMP)/ Good Laboratory Practices (GLP), ERP- SAP & Oracle, Automation- SCADA, EBR, Pharma 4.0, Enterprise System startups, New Product Development including QbD, Quality Management Systems (Change Control, CAPA, event management etc), IT, EHS, and Facility Builds (from URS/FS through BOD, detailed design, construction and validation for both new construction as well as major refit green/brown field). Experience in nasal delivery platforms, parenteral injectables, biotechnology, oral solid dose (including soluble film), as well as primary and secondary packaging. Skilled in facility and operations planning, capital planning, P&L, establishing meaningful and impact driving KPIs, COGS management, OpEX (lean six sigma green belt), design build and automation of enterprise systems (bspoke and COTS).

Listed skills include Validation, Fda, Biotechnology, Gmp, and 40 others.

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  Excelsior University

  Nuclear