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Department: GTD Global Technical Development
Team: R&D, Pharmacovigilance & Regulatory Affairs
Job Type: Direct Employee
Contract Type: Permanent
Location:Parma, ITAbout 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 (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 here
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 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 & Development
Our 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, global technical development, 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), Toronto (Canada) and Shanghai (China).
Who we are looking forPurpose
Testing of materials suitable for preclinical and clinical development, and registration of new drug substances, including starting materials and intermediates, also in accordance with GMP/c GMP
Main Responsibilities- Method development to characterize new starting materials, intermediates and active ingredients
- Execution of the activities described in the method validation/transfer protocols
- Execution of the activities described in the stability protocols
- Execution of the activities described in the forced/stressed degradation protocols
- Analytical testing of materials for clinical use and non-clinical use
- Analytical testing to support process development of new active ingredients
- In Process Controls during new active ingredients manufacturing campaigns
- Analytical testing to verify plant cleaning
- Equipment management
- Support to the management of analytical non conformities (deviations, OOS, OOT, OOE)
- Promote the technological innovation, scientific understanding and best practices
- Promote operational excellence (processes/best practices) and continuous quality improvement
- Preparation and revision of technical documentation
- 5 years as Analytical Technician in Quality Controls laboratories of active ingredients manufacturing companies, pharmaceutical companies, chemical companies
High school diploma in Chemistry
LanguagesEnglish – basic knowledge
Technical Skills- Very good knowledge of UHPLC with UV-Vis/DAD/PDA and Mass detectors
- Very good knowledge of GC with Flame Ionization and Mass detectors
- Good knowledge of IR, Raman, NIR, UV-Vis spectrophotometer, DSC, TGA, potentiometric titrators in aqueous and non-aqueous medium, KF volumetric and coulometric titrators, ICP-MS, laser diffraction equipment for particle size distribution measurement
- Good knowledge of the Good Manufacturing Practice rules applied to the analytical laboratories
- Good documentation editing skills
- Good knowledge of the univariate statistic
- Good knowledge of the standard informatic tools
- Knowledge of p Ka and log P/D determination
- Knowledge of problem-solving techniques
- Knowledge of the multivariate (PCA, Do E) statistic
- Decision making
- Planning and organizational skills
- Team working
- Continuous learning
- Goal orientation
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. 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.