Implementation of QbD on analytical method development. Assessment and Introduction of Process Analytical Technologies in the processes. (Continued in previous profile below)

Creation of the Unit “Process Analytics” and integration of the group Cell line Development. Centralization of all process analytical activities and technologies. Guarantees analytical qualityin the department Bacterial Drug Substance Development in close collaboration with the process related units (CLD, USP, DSP and Pilot) and with the departments TD-Analytics, QC and QA- Development. Suitability assessment, developability, development and pre-validation of new analytical methods and in… Show more Creation of the Unit “Process Analytics” and integration of the group Cell line Development. Centralization of all process analytical activities and technologies. Guarantees analytical qualityin the department Bacterial Drug Substance Development in close collaboration with the process related units (CLD, USP, DSP and Pilot) and with the departments TD-Analytics, QC and QA- Development. Suitability assessment, developability, development and pre-validation of new analytical methods and in process controls, generated internally or in collaboration with research institutions. Show less

Creation of the Unit and group “Cell Line Development”. Rationalization of the project fluxes and clear definition of interactions and collaborations between departments. Implementation of Quality in cell line development and USP, in close collaboration with the departments TD-Analytics and QbD. Support QC with pre-validation and validation activities for closure of DR and CAPA. Evaluation and developability of new production systems, generated internally or in collaboration with research… Show more Creation of the Unit and group “Cell Line Development”. Rationalization of the project fluxes and clear definition of interactions and collaborations between departments. Implementation of Quality in cell line development and USP, in close collaboration with the departments TD-Analytics and QbD. Support QC with pre-validation and validation activities for closure of DR and CAPA. Evaluation and developability of new production systems, generated internally or in collaboration with research institutions. Generation and maintenance of a Novartis global cross- divisional cell bank. Show less

Administration of the laboratories Fermentation Development : Definition of objectives and work plans; Identification of necessary resources (human e materials); Respect of timelines, qualitative and quantitative outputs agreed upon; Application of HSE, compliance and quality procedures; Training and coaching of direct reports (7 persons), performance review and definition of development plans; Identification of strategic investments and respect of predefined budget objectives.Support to… Show more Administration of the laboratories Fermentation Development : Definition of objectives and work plans; Identification of necessary resources (human e materials); Respect of timelines, qualitative and quantitative outputs agreed upon; Application of HSE, compliance and quality procedures; Training and coaching of direct reports (7 persons), performance review and definition of development plans; Identification of strategic investments and respect of predefined budget objectives.Support to company projects – Active participation to project meetings; Lead projects through different decision making phases; Proactive resolution of phase related problems in collaboration with other units and/or departments; Write/Revise/approve Technical Reports, presentations, publications and patents.Emerging activities – Management of interactions with HSE and sanitary service for the department “Protein Biochemistry” and update/deployment of procedures. Cooperation with department head in translation of business strategies/objectives/visions; Definition of common objectives, active collaboration and team building with other units and departments; Construction and management of external contacts to guarantee constant update of scientific knowledge, acquire advanced technologies, create high level international projects/platforms; Participate to congresses, national and international meetings in order to strengthen external credibility and prestige of the company. Show less

Startup of laboratory. See description above but managing two persons and major part of time spent on industrial research.