MSAT Project Lead

ppbJob Title: MSAT Technical Lead (DS Biologics) /b /p /brpbLocation: Switzerland or Remote /b /p /brpbDuration: ASAP until 31 December 2026 /b /p /brpbFTE: 100% /b /p /brpbTravel: Up to 30% /b /p /brpOur client is seeking an experienced MSAT Technical Lead with deep expertise in Drug Substance (DS) Biologics manufacturing to support commercial and clinical biologics operations.

The successful consultant will provide technical leadership across manufacturing process validation, technology transfers, lifecycle management initiatives, regulatory support, and external manufacturing oversight. /p /brpThis role requires a strong scientific background in biologics manufacturing, particularly mammalian cell culture, and extensive experience within MSAT, technical operations, process validation, and external manufacturing environments. /p /brh3Key Responsibilities /h3 /brul /brliAct as SME for DS Biologics manufacturing processes. /li /brliServe as process owner for DS Biologics validation activities. /li /brliLead MSAT projects focused on process optimisation, yield enhancement and cost reduction. /li /brliDrive process changes, investigations, major deviations, risk assessments and CAPAs. /li /brliReview and approve SOPs, manufacturing instructions and technical

documentation. /li /brliOversee technical studies, process validations and qualification activities. /li /brliContribute to APR/PQR preparation and review. /li /brliSupport CMC regulatory submissions, variations and health authority responses. /li /brliAssess and support onboarding of new biologics CMOs/CDMOs. /li /brliLead technology transfers, scale-up activities and commercial manufacturing implementations. /li /brliMonitor manufacturing performance and recommend process improvements. /li /brliIntroduce innovative technologies supporting manufacturing efficiency and robustness. /li /brliRepresent MSAT/SAT in governance forums and cross-functional project teams. /li /brliSupport continuous improvement initiatives across systems, processes and templates. /li /br /ul /brh3Required Qualifications /h3 /brh3Education /h3 /brul /brliDegree in Biotechnology, Biology, Pharmacy, Biochemical

Engineering or related scientific discipline. /li /br /ul /brh3Experience /h3 /brul /brli10+ years of experience in commercial biologics drug substance manufacturing. /li /brliStrong MSAT and technical operations experience. /li /brliExtensive experience supporting external manufacturing organisations. /li /brliHands-on experience with mammalian cell culture. /li /brliExperience with cell banking and working cell bank implementation. /li /brliExperience leading validation activities for biological products. /li /brliTechnology transfer and scale-up experience. /li /brliExperience managing manufacturing deviations, CAPAs and change controls. /li /brliRegulatory submission support and health authority interaction experience. /li /br /ul /brh3Preferred Experience /h3 /brul /brliClinical manufacturing experience. /li /brliBacterial fermentation knowledge. /li /brliScale-down model

development and qualification. /li /brliProduct launch and CMC development experience. /li /br /ul /p