About usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more hereWe are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. Chiesi Research & DevelopmentOur R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, chemical manufacturing and controls, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden) and Toronto (Canada).Who we are looking forPurposeDesign, monitor and data elaboration of analytical development studies relevant to inhalation (pMDIs/DPI) and/or biological drug products Main Responsibilities- Support to CTS release.- Study Monitor of analytical method development studies.- Study Monitor of analytical method validation/transfer studies.- Study Monitor of stability studies.- Study monitor of active ingredients characterization studies.- Support to formulation and process development studies of drug products.- Support to scale up for drug products and active ingredients process.- Support to device characterization studies.- Support to the critical quality attribute identification of APIs and drug products.- CRO managementExperience RequiredAt least 5-year experience on inhalation products and/or biological drug productsEducationMaster degree or PhD in Chemistry or Chemical and Pharmaceutical TechnologiesLanguagesGood working knowledge of English. Italian would be advantageous Technical Skills- ???Good knowledge of the spectrophotometric, diffractometric, calorimetric, potentiometric and chromatographic techniques.- Good knowledge of the univariate and multivariate (PCA, DoE) statistic.- Good knowledge of the standard informatic tools.- Good knowledge of the analytical characterization of inhalation devices.- Good knowledge of the analytical characterization of inhalation active ingredients and drug products.- Good knowledge of the analytical tools for the characterization of the inhalation performances (DUSA/USCA/NGI/ACI).- Good knowledge of GMP/cGMP and guidelines (ICH, EMEA, PQRI, Health Canada) related to the pharmaceutical development of inhalation products.- Good knowledge in biological product development from preclinical/early phase to the late phase/Market is considered as a plusSoft SkillsAnalytical skills Planning and organizational skills Quality orientation Team working What we offerYou would join a dynamic, fast-growing, challenging and friendly environment. In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
