Senior Analytical Development Specialist
2 settimane fa
We are Chiesi, an international research-focused pharmaceutical and healthcare group with over 85 years of experience, operating in 31 countries with more than 7,000 employees.
Our MissionWe strive to improve people's quality of life by acting responsibly towards society and the environment, researching, developing, and marketing innovative drugs in our main therapeutic areas.
Job DescriptionWe are seeking a skilled Analytical Scientist to join our team in Parma, Italy.
As an Analytical Scientist, you will be responsible for:
- Design, monitor, and data elaboration of analytical development studies relevant to inhalation (pMDIs/DPI) and/or biological drug products.
- 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 is also a key aspect of this role. We require at least 5 years of experience in inhalation products and/or biological drug products, as well as a Master's degree or PhD in Chemistry or Chemical and Pharmaceutical Technologies. Good working knowledge of English is essential, with Italian being advantageous.
Technical Skills include:
- Good knowledge of spectrophotometric, diffractometric, calorimetric, potentiometric, and chromatographic techniques.
- Good knowledge of univariate and multivariate (PCA, DoE) statistics.
- Good knowledge of standard informatic tools.
- Good knowledge of analytical characterization of inhalation devices.
- Good knowledge of analytical characterization of inhalation active ingredients and drug products.
- Good knowledge of analytical tools for the characterization of 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 of biological product development from preclinical/early phase to the late phase/Market is considered as a plus.
Soft Skills include:
- Analytical skills
- Planning and organizational skills
- Team working
- Quality orientation
What We Offer
You will join a dynamic, fast-growing, challenging, and friendly environment. We invest in continuous training, learning, and development, striving to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being. 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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