MSAT Manager

MSAT Manager – Small Molecule Drug Substance Development & External ManufacturingAllerton Bishop is partnering with a successful London-based speciality pharmaceutical company to appoint an experienced MSAT Manager. The MSAT Manager will provide technical oversight of drug substance development and manufacturing activities, working closely with external CDMO partners across both clinical and commercial programmes.The role will play a key part in process development, scale-up, technology transfer and lifecycle management, working cross-functionally with CMC, Quality, Regulatory and Supply Chain teams.The responsibilities for the MSAT Manager will be:Provide technical oversight of drug substance development and manufacturing activities across clinical and commercial programmes.Lead the technical relationship with CDMO partners, ensuring projects are delivered to agreed quality, technical and timeline requirements.Manage process development, scale-up and technology transfer activities from laboratory through to commercial manufacturing.Provide MSAT input into CMC development strategies, regulatory submissions and product lifecycle management.Lead technical investigations, process improvements and manufacturing activities in collaboration with external partners and internal stakeholders.The successful candidate for the MSAT Manager will demonstrate the following:MSc or PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences or a related scientific discipline.Relevant experience within pharmaceutical drug substance/API development or manufacturing.Strong technical experience in MSAT, process development, scale-up, technology transfer and/or CMC.Experience managing CDMO/CMO relationships, ideally across clinical and commercial manufacturing (Desirable)Good understanding of GMP, CMC and regulatory requirements within pharmaceutical drug substance manufacturing.The right to work in the UK is essential - visa sponsorship will not be availableMSAT Manager | MS&T Manager | Drug Substance | API | Process Development | Process Scale-Up | Technology Transfer | CMC | External Manufacturing | CDMO | Pharmaceutical Manufacturing | GMP | Clinical Manufacturing | Commercial Manufacturing | Speciality Pharma