Overview

Head of MSAT - Global CDMO. QP Group has partnered with a general CDMO, based in Spain, who are actively looking to add a Head of MSAT to cover the transfer of both Drug Substance processes (cell culture and purification) and Drug Product processes (formulation and fill-finish). The Head of MSAT will define the strategy, build the team, and ensure the robust and compliant transfer of manufacturing processes from Process Development into GMP Manufacturing for internal programs, and from external customers in a CDMO context — covering early- and late-stage projects.

Responsibilities

• Oversee planning, execution, and documentation of MSAT activities for both Drug Substance (upstream & downstream) and Drug Product (formulation & fill-finish).
• Ensure successful scale-up, process adaptation, and Process Performance Qualification (PPQ).
• Guarantee knowledge transfer and training of Manufacturing and Fill-Finish personnel.
• A...