Job Description Summary
As USP SMEs, responsible for technology transfers, process lifecycle management, manufacturing support, validation support, and technical governance across Sandoz manufacturing sites and external partners.
Job Description
Position Purpose:
As USP SMEs, responsible for technology transfers, process lifecycle management, manufacturing support, validation support, and technical governance across Sandoz manufacturing sites and external partners.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
Technical support
• To provide support Upstream manufacturing processes across commercial products.
• Serve as SME for fed-batch, intensified fed-batch, and continuous perfusion upstream process control strategies.
• Support resolution of complex technical manufacturing issues and investigations.
Innovation & Emerging Technologies
• Evaluate emerging upstream processing technologies, digital solutions, advanced analytics, automation platforms, single-use technologies,
and manufacturing innovations for applicability across the biologics network.
• Assess technical feasibility, business value, implementation risks, and potential impact on product quality, process robustness, cost of goods, and supply reliability.
• Partner with Manufacturing, Process Development, Engineering, Digital, and external technology providers to pilot and industrialize creative solutions.
• Support implementation of approved technologies and ensure effective knowledge transfer across manufacturing sites and CMOs.
Manufacturing Support
• Ensure timely scientific support for routine manufacturing operations.
• Provide support investigations related to process deviations, atypical results, and process performance excursions to in-house facilities as well as CMOs as needed.
• Support root cause analysis and implementation of effective CAPAs.
Process Lifecycle Management
• Perform continued process verification (CPV) programs across commercial products.
📌 Tech associate USP MS&T CoE (India)
🏢 Sandoz
📍 India