Pds Formulation Scientist

4 settimane fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

**What you will do**

As a part of our Formulation - Pharmaceutical Development team you will be supporting the manager in ensuring process development activities for batches destined for clinical trials and for commercial manufacturing.
In addition, you will ensure the scale up/ technology transfer and processes of new sterile products into Pharmaceutical Development (PDS) Department and commercial sites.

**Responsabilities**
- Ensure the pre-formulation and formulation studies of new sterile injectable pharmaceutical forms.
- To oversee the manufacturing activities for registration batches to support regulatory submissions.
- To transfer formulations and manufacturing processes into GMP manufacturing.
- To conduct formulation development work including pre-formulation, formulation characterisation, process development and scale-up.
- To assist manufacturing operations in problem solving, investigations and corrective actions for registration and scale up batches.
- Leads meetings/call with clients updating on projects and activities. Develops realistic proposals and timelines if need.
- Implements continuous improvement projects to drive improved process efficiency and efficacy.

**How you will get there**
- Bachelor’s Degree in Chemistry, Pharmacy or CTF
- Experience in industrial pharmaceutical formulations
- Fluent English
- Knowledge of the characterization techniques of the lyophilized products (DSC, FDM)
- Knowledge of characterization of formulations (DLS, HIAC, MFI, TFF, osmolality, viscosity and density)
- Must be able to work independently as well as work with a diverse team.
- Knowledge of Design of experiment (DoE)

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