Descripción de la oferta
***Head of MSAT - Global CDMO***QP Group has partnered with a global 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 activitiess 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.Act as the main interface between Process Development, GMP Manufacturing, Fill-Finish Operations, QA, Regulatory Affairs, and Engineering.Provide technical leadership and act as a subject-matter expert for internal development projects and CDMO client programs.Support troubleshooting and continuous improvement in commercial manufacturing and formulation.Ensure all transfer activities comply with GMP and global regulatory requirements.Provide input to CMC regulatory documentation for both Drug Substance and Drug Product.Establish and lead the MSAT group within [Technical Operations or R&D].Recruit, develop, and mentor specialists in Drug Substance and Drug Product transfer.Define best practices, procedures, and KPIs for MSAT activities activitiesExperience Required:PhD in Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related field.Minimum10 years of experience in the biopharmaceutical industry, with at least 5 years in MSAT, MS&T,late-stage Process Development, or Formulation Development.Solid experience in Drug Substance MSAT activities (cell culture and purification) is required. Additional experience in Drug Product (formulation and fill-finish) will be considered a strong asset.Proven experience in process scale-up, MSAT activities, and validation under GMP.Familiarity with CMC regulatory requirements and process validation guidelines.Please apply directly or via harry@qpexec.com
