Senior Analytical Development Specialist
14 ore fa
Chiesi is an international pharmaceutical and healthcare group with a rich history spanning over 85 years. Headquartered in Parma, Italy, the company operates in 31 countries with a global workforce of over 7,000 employees.
Our MissionWe strive to improve people's quality of life by acting responsibly towards society and the environment. Our commitment to research and innovation has enabled us to develop cutting-edge drugs in various therapeutic areas.
Award-Winning CompanyWe are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, recognizing our high social and environmental standards. Our transparent and ethical behavior sets us apart as a reliable partner in the industry.
Culture and ValuesWe believe that our people are our most valuable asset. We foster a diverse and inclusive culture that celebrates individuality and promotes teamwork. Our strong set of shared values and behaviors guides us in attracting and retaining top talent who share our vision.
R&D TeamOur R&D team is a critical component of our business, focusing on pipeline projects across discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, and R&D project management.
Job OverviewWe are seeking a skilled Senior Analytical Development Specialist to join our dynamic team. In this role, you will design, monitor, and data elaborate analytical development studies relevant to inhalation products and/or biological drug products.
Main Responsibilities:- Support 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 formulation and process development studies of drug products
- Support scale up for drug products and active ingredients process
- Support device characterization studies
- Support 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 spectrophotometric, diffractometric, calorimetric, potentiometric, and chromatographic techniques
- Good knowledge of univariate and multivariate statistic (PCA, DoE)
- 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 characterization of inhalation performances (DUSA/USCA/NGI/ACI)
- Good knowledge of GMP/cGMP and guidelines (ICH, EMEA, PQRI, Health Canada) related to pharmaceutical development of inhalation products
- Dynamic and fast-growing work environment
- Ongoing training, learning, and development opportunities
- Flexible working approach and remote working options
- Relocation support and tax assistance service for foreign colleagues
- Competitive salary and benefits package
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