Senior Analytical Scientist CMC
Senior Analytical Scientist CMC
Recordati
Milan, Italy
Your contribution/mission
The position foresees:
- Provide analytical support for marketed and new development products in collaboration with group internal stakeholders and/or external CMOs, CDMOs, and CROs in Italy and abroad;
- Review current approved analytical protocols and test procedures based on new or revised regulatory requirements or on health authorities’ deficiency letter or request;
- Skills in development of analytical methods, as an example HPLC, UHPLC and Dissolution Test;
- Support laboratory performance goals and monitor current performance against targets;
- Provide technical support to the manufacturing team regarding issues that arise and are detected in the laboratory and also for trials that are performed as part of root cause investigation;
- Contribute to laboratory management, such as ordering supplies, organizing maintenance schedules, organizing samples inventory, as necessary;
- Willingness to learn new techniques and perform multiple tasks simultaneously.
Your profile
Requirements:
- Proven track record in applying analytical techniques to solve challenging problems;
- Experience and knowledge in ICH guidelines, stability data management, and cGMP;
- 5+ years of experience in CMC pharmaceutical sciences focussed on analytical development;
- Knowledge of analytical statistics tools and applications, perform trend analysis and evaluation;
- Experience with analytical techniques for small molecules required, including UPLC/HPLC, GC, KF, UV/Vis, and IR. Particle size analysis, dissolution testing, DSC, TGA, and XRPD are a plus;
- Knowledge of CMC regulations is a plus;
- Knowledge in LC/MS, Proteomics, and peptide analysis techniques and regulations is a plus.
Skills
- Fluent English both spoken and written;
- Self-directed and motivated;
- Collaborative and good team player;
- Strong organizational skills and communication skills.
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