R&D Analytical Scientist

4 settimane fa

Milano, Lombardia, Italia Novasyte A tempo pieno

Our client, Chiesi Farmaceutici - one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry - in order to expand their staff, entrusted to IQVIA the recruitment of 3 Analytical Scientist - Developing pharmaceutical products - who can join an exciting working environment in a dynamic and international atmosphere.
JOB DESCRIPTION:
Support analytical activities required for producing information and documentation suitable for preclinical and clinical development and registration of drug products, including excipients and intermediates, with particular focus on quality in accordance with GMP/cGMP.
RESPONSIBILITIES:
Developing pharmaceutical products (small molecules, new chemical entities, biological products, excipients, intermediates, Drug Products) in line with QRM principles by designing and evaluating the necessary activities both internal and c/o CRO:
- development, validation and transfer of analytical methods
- stability studies set-up and management
- drug products characterization studies
- extractables and leachables studies
- studies to support formulation and manufacturing process development (feasibility, refinement, scale-up, )
- Execute the development strategy of the assigned project
Contribute to the scientific understanding for the product development area
Preparation and revision of technical documentation in line with quality and regulatory requirements and according to relevant internal procedures
Writing/reviewing of regulatory documentation (CTD/NDA, IMPD/IND, Q&A, Briefing documents for Scientific advice)
Operate according to the related SOPs, cGMPs, safety guidelines and policies as necessary to accomplish daily tasks.
Support Change Control Evaluation
Support quality investigations (Deviations or OOS, Complaints)
**REQUIREMENTS**:
- At least 2/3 years of experience in a similar position in a pharmaceutical company or CRO.
TYPE OF CONTRACT:
Permanent contract
Chemical contract
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.
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