CBC Process Expert

Salary Range: CHF74,200.00 - CHF137,800.00 Band Level 3 Job Description Summary Provide front line expert support for all process‑specific issues to production in Basel BDSS Cell Bank Center, to ensure execution of processes on‑time, continuously improving in quality and productivity, performed in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE, NOSSCE). Act as a Subject Matter Expert and support Large Molecule Platform and other customers (eg. External Supply Operations, Quality, Novartis Technical Operations Supply Chain, etc) on Cell Banks management procedures. Job Description Major accountabilities Lead the lifecycle management of cell banks, ensuring availability, inventory control, manufacturing, qualification, registration, and compliance with global regulatory requirements and product registrations. Act as the primary technical and regulatory contact for cell bank and manufacturing activities, coordinating with global functions, development teams, manufacturing sites, and external stakeholders. Serve as Subject Matter Expert (SME) for assigned products and processes, providing real‑time shop floor support, troubleshooting technical issues, and ensuring rapid implementation of corrective actions. Ensure timely and GMP‑compliant execution of manufacturing operations, including batch monitoring, batch record review, process validation, changeovers, and maintenance of production documentation. Drive training, qualification, and capability development of production teams by designing, delivering, and supporting technical training and qualification programs. Lead deviation, complaint, OOS/OOE, CAPA, and root cause investigation activities, ensuring effective resolution and continuous process robustness. Maintain inspection readiness and regulatory compliance by overseeing quality systems, change controls, validation and qualification activities, GMP documentation, and interactions with health authorities and auditors. Monitor and improve product and process performance through trend analysis, CPV, APQR/OPV contributions, KPI reporting, risk assessments, and implementation of process improvements. Manage cross‑functional projects, technology transfers, process changes, equipment investments, and technical documentation, ensuring delivery on time, within budget, and in compliance with cGMP and HSE requirements. Champion Quality, HSE, and Operational Excellence culture by promoting continuous improvement, 5S practices, compliance oversight, supplier and contractor governance, and overall quality and safety performance across the manufacturing organization. Essential requirements BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree. Minimum 3-year experience in process support role on the shop floor of GMP manufacturing . Excellent knowledge of Upstream processes using mammalian cells. Very good understanding of cell bank processes (manufacturing, testing, and storage). Excellent interpersonal