Biotech Engineer / PAT Specialist

Responsable du transfert techniqueResponsable des activités de transfert de technologie au niveau du site (interne, entrant et sortant), y compris toute mise à l’échelle ou autre adaptation de processus.Diriger l’équipe de projet de transfert technique sur le site et assurer une liaison efficace avec les fonctions concernées (par exemple, le développement technique, la chaîne d’approvisionnement, l’unité de production, le contrôle de la qualité, le HSE, d’autres sites).Délégué syndical de produitsPosséder la connaissance des processus du ou des produits attribués tout au long du cycle de vie commercial, maintenir la surveillance de la capacité des processus, par le biais de l’analyse des tendances des données et de l’analyse statistique des variables critiques, en veillant à ce que les processus soient robustes, en état de validation continue et en amélioration continue.Assurer un flux continu de connaissances et d’informations entre les fonctions, et avec d’autres sites le cas échéant, en mettant l’accent sur le(s) produit(s) attribué(s). Fournir un soutien technique et scientifique de deuxième ligne.Délégué techniqueFournit au site les connaissances et l’expertise spécialisées, en tant qu’expert en la matière (SME), de procédés pharmaceutiques ou de technologies de procédés spécifiques (par exemple, responsable technique pour la galénique, pour le pelliculage, les produits biologiques – en amont ou en aval, etc.).Superviser les processus et les normes afin de maintenir et d’améliorer les technologies de fabrication existantes et de mettre en œuvre de nouvelles technologies de fabrication novatrices.Responsable de la validationResponsable de l’élaboration, de la mise en œuvre et de la gestion des stratégies de validation des processus du site, de validation de l’emballage primaire, de validation du nettoyage et de revalidation afin de répondre aux exigences cGMP et de qualité dans les délais et le budget impartis afin de s’assurer que les programmes sont conformes aux attentes des autorités réglementaires et aux SOP connexes.Chercheur principal MSAndTConcevoir, planifier, exécuter, interpréter et rendre compte d’expériences scientifiques sous la direction du chef de département afin de contribuer aux stratégies et aux objectifs globaux de MSAndT.

Key Responsibilities Implement high-throughput approaches for real-time bioprocess monitoring and optimization, leveraging automation, online analytics and advanced data analysis.Lead technology development and continuous improvement initiatives supporting process intensification.Develop and deploy spectroscopy-based Process Analytical Technology methods, including Raman and dielectric spectroscopies.Support the implementation of innovative technologies that advance manufacturing processes and operational performance.Interpret spectral data and establish secure data management and analysis procedures aligned with Good Manufacturing Practice requirements.Apply multivariate data analysis methods for model development, validation and ongoing maintenance.Partner with Production, , Engineering and Automation teams to integrate new technologies in commercial manufacturing processesAnalyze and communicate complex datasets through clear technical reports and presentations to support informed decision-making. Essential Requirements University degree in Biotechnology, Chemical Engineering or a related scientific field.2–5 years of experience in the biopharmaceutical industry, with practical experience in biotechnology processes.Strong knowledge of advanced statistical methods and Multivariate Data Analysis, applied within a biotechnology environment.Proven experience with cell culture and/or purification processes, including process scale-up and scale-down.Experience working with complex process and spectral datasets, including developing, validating and interpreting data models.Good understanding of the pharmaceutical regulatory environment, including Good Manufacturing Practices, Quality Assurance, Quality Control and International Council for Harmonisation guidelines.Fluent English, with strong communication, problem-solving and cross-functional collaboration skills. Desirable Requirements Experience with Raman spectroscopy or other spectroscopy-based Process Analytical Technology methods.Experience with online biomass monitoring or related real-time bioprocess analytical technologies.Previous experience with technology integration in GMP environments is a plus.We offer you a temporary contract, for the period of covering maternity leave.Benefits & Rewards At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. Expected Annual Base Salary Range for role: € 44,000 to € 81,800 The base 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. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave. Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics. Read our brochure to learn more about our global total rewards offering: 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, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process. Commitment to Diversity and Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.