MS&T Specialist

4 giorni fa

L'Aquila, Abruzzo, Italia Jefferson Wells Italia A tempo pieno

We are looking for a Manufacturing Science & Technology Senior Specialist on behalf of our Client.

Short Role Description / Purpose:

  • Perform Technology Transfer (IN & OUT), process scale up and Validation at industrial scale;
  • Provide technical & scientific support during commercial phase to solve trouble issue (Life Cycle Management)

Main Responsibilities:

  • Lead the technology transfer projects by technical standpoint for products already registered.
  • Perform Process Validation /re-validation.
  • Address, in agreement with the line manager, the technical feasibility of new products including the scale up at industrial level, Process Validation pre and post registration.
  • Perform scale up studies and technical batches on industrial scale.
  • Support Quality team during Audits performed by partners or regulatory authorities as subject matter expert on technical aspects.
  • Implement and / or participate in existing product maintenance projects for recurring issues or collaborate on the introduction of new suppliers / third parties providers;
  • Perform studies related to changes of the critical components of the products (e.g. API, excipients, primary packaging) and manufacturing processes (e.g. batch size increase, process optimization, change of critical equipment) due to external factors (e.g. suppliers, cost reductions or business continuity)
  • Provide Technical and Scientific support during the preparation of the CTD/NDA/BLA Registration Technical Part;
  • Propose corrective and preventive measures to improve process robustness by developing, with the possible support of other functions, feasibility studies and related technical / economic analysis.
  • (...)

Main Requirements:

  • Technical or Scientific Degree (Chemical Pharmaceutical Technology, Engineering, Chemistry, Mathematics/Physics/Natural sciences);

  • Pharmaceutical Science and Process Development knowledge and experience of most relevant dosage forms (OSD, Oral Liquid, Sterile)

  • Statistics applied to pharmaceutical processes

  • Specific Scale up and Technology Transfer competencies

  • Knowledge and Experience in validation of pharmaceutical production processes in various dosage forms (OSD, Oral Liquid, Sterile) -

GMP standards knowledge.

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