Date: 17 Aug 2024 Department: GTD Global Technical Development Team: RD, Pharmacovigilance Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than 7,000 employees.
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards.
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.
Chiesi Research Development Our RD team represents a fundamental asset for the business.
It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, RD project and portfolio management.
Who we are looking for Purpose Design, 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 management.
Experience Required At least 5-year experience on inhalation products and/or biological drug products.
Education Master degree or PhD in Chemistry or Chemical and Pharmaceutical Technologies.
Languages Good 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 plus.
Soft Skills Analytical skills.
Planning and organizational skills.
Team working.
Quality orientation.
What we offer You 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.
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.
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