CBC Process Expert

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 banks and manufacturing areas, 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 timely implementation of corrective actions.Ensure timely and GMP-compliant execution of manufacturing operations, including batch monitoring, batch record review, process validation, changeover, 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 auditors and health authorities. Monitor and improve product and process performance through run analysis, 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 developing a continuous improvement, safety, and quality culture, as well as supplier and vendor management. Essential requirements: BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree. Minimum 3-year experience in process support role in a GMP manufacturing environment. Excellent knowledge of Upstream processes using mammalian cells. Very good understanding of cell bank processes (manufacturing, testing, and storage). Excellent interpersonal & communication skills. Fluent in English and German. Rewards At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in like insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and a minimum of 14 weeks paid parental leave. Expected Annual Base Salary Range for role: CHF 74,200 - 137,800.The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies, and experience in accordance with the Novartis pay setting policy and upon joining Novartis, will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Further details will be provided during the application process. Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse and inclusive environment. For more information about our total rewards, please read our handbook: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf Note: Benefits and compensation may vary by country and are subject to local legal requirements. A full overview of your compensation package will be communicated separately to you during the application process. Accessibility and accommodation: Novartis is committed to providing reasonable accommodation to all individuals with for any part of the recruitment process. If you need a reasonable accommodation, please send an e-mail to [email protected]. Commitment to Diversity and Inclusion / EEO: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.