Senior Analytical Development Scientist
2 mesi fa
Chiesi is a leading international pharmaceutical and healthcare company with a rich history of innovation and a strong commitment to improving people's quality of life. With over 85 years of experience, we operate in 31 countries and employ over 7,000 talented individuals worldwide.
Our MissionWe strive to achieve our mission by researching, developing, and marketing innovative drugs in our main therapeutic areas. Our team of experts is dedicated to delivering high-quality products that meet the needs of patients and healthcare professionals.
Our ValuesWe believe that our people are our greatest asset, and we invest in their growth and development. Our strong set of shared values and behaviors guides our actions and decisions, and we are committed to promoting a transparent and ethical behavior at all levels.
Our TeamWe are a global family made up of diverse individuals from different cultures, backgrounds, and expertise. Our team is passionate about delivering exceptional results and making a positive impact on people's lives.
Job SummaryWe are seeking an experienced Analytical Scientist to join our team in the development of inhalation products. The successful candidate will be responsible for designing, monitoring, and data elaboration of analytical development studies relevant to inhalation products.
Key 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
- At least 5-year experience on inhalation products and/or biological drug products
- Master degree or PhD in Chemistry or Chemical and Pharmaceutical Technologies
- Good working knowledge of English
- Italian would be advantageous
- 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
- Analytical skills
- Planning and organizational skills
- Team working
- Quality orientation
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