MS&T Specialist

Jefferson Wells Italia; Abruzzo; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading consulting firm is seeking a Manufacturing Science & Technology Senior Specialist in Abruzzo, Italy. The ideal candidate will lead technology transfer projects, validate processes at industrial scale, and provide technical support for regulatory submissions. Strong knowledge of pharmaceutical science and experience in various dosage forms are essential. Join a dynamic team to enhance product robustness and ensure compliance with GMP standards.

Competenze

• A degree in Chemical Pharmaceutical Technology, Engineering, Chemistry, Mathematics, Physics, or Natural sciences is required.
• Experience in pharmaceutical production processes is crucial.
• Knowledge of GMP standards is essential.

Mansioni

• Lead technology transfer projects and ensure successful product registration.
• Conduct process validation and re-validation at industrial scale.
• Address the technical feasibility of new products including scale-up studies.
• Support Quality team during audits as a subject matter expert.
• Provide scientific support for CTD/NDA/BLA registration.

Conoscenze

Pharmaceutical Science and Process Development

Statistics applied to pharmaceutical processes

Specific Scale up and Technology Transfer competencies

GMP standards knowledge

Formazione

Technical or Scientific Degree

Descrizione del lavoro

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.