Senior Analytical Scientist CMC
4 settimane fa
We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.
At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.
This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.
Recordati. Unlocking the full potential of life. Job Purpose
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 Required Skills and Experience
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 Self-directed and motivated Collaborative and good team player Strong organizational skills and communication skills Required Languages
Fluent English both spoken and written At Recordati we believe in people Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential. We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief. If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.
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