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PDS PPT Clinical Trial Manufacturing Scientist

LOCATION:
Italy - Ferentino


JOB DESCRIPTION

MAIN RESPONSIBILITIES:

  • 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

REQUIREMENTS:

  • 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.

Degrees of interest: CTF, Chemistry, Engineering

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