PDS PPT Clinical Trial Manufacturing Scientist
Italy - Ferentino
- Follow the tech transfer of the products from clients to PDS manufacturing area.
- Select the materials to be used during the manufacturing of liquid and lyophilized products and decides the manufacturing process flow.
- Support the manufacturing organization for an optima scheduling of the activities and prepares the documentation necessary for the compounding, filling, crimping and visual inspection steps.
- Have in charge the internal and external approval process.
- Have in charge the technical responsibility of the project assigned.
- Prepare the technical documentation required as support form manufacturing stages according to NBF and internal SOP.
- Participate to clinical/commercial batches manufacturing inside PDS sterile suite.
- Follow the technology transfer from donor sites to Patheon Ferentino and, if required the transfer from Patheon Ferentino to other Patheon’s site inside the PDS network.
- Check of the scheduling and verify that all activities under control are in line with the time line of the project.
- Assure the storage of the documentation generated according to internal procedures.
- Contribute, according to internal policy, to training of development lab technicians.
- Update the clients about the state of the project and alert the direct reports of deviations respect to routinely activities.
- Support the development lab in process flow definition for the projects destined to future scale up to GMP area
- Degree in CTF, Chemistry, Engineering
- Good level of English
- An experience in a related field will be considered as a plus
We offer a temporary contract of 6 months.
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