Technical Transfer Lead

Novartis Farmacéutica; Bari; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company in Italy is seeking a Technical Transfer Lead to oversee technology transfer activities at the site level. The successful candidate will coordinate cross-functional teams, ensure documentation compliance, and support validation processes. The ideal applicant should have relevant experience in a GMP environment and proficiency in both Italian and English.

Competenze

• Previous solid experience in a similar role within Tech Transfer / MS&T / QA / Production department of a GMP environment.
• Ability to ensure timely availability of technical documentation.

Mansioni

• Lead the technical transfer project team at the site.
• Coordinate project activities and ensure compliance with guidelines.
• Establish site project plans and resource needs.

Conoscenze

Technical development coordination

Risk assessment

Project management

Technical feasibility assessment

Fluency in English

Fluency in Italian

Formazione

Scientific Degree

Descrizione del lavoro

The Technical Transfer Lead is responsible for technology transfer activities at site level (within, inbound and outbound), including any scale-up or other process adaptations.

Leading technical transfer project team at site and liaises efficiently with involved functions (e.g. Technical Development, Supply Chain, Production Unit, Quality Control, HSE, other sites.).

About the Role

Major accountabilities :

• Review and update Quality Risk Assessment (QRA) prior to transfer and prior to validation, adapt control strategy if needed.
• Ensure that all relevant technical information and documentation for validation is available.
• Define pre-validation / validation strategy incl. process, cleaning, packaging and supportive studies (e.g., hold times). Coordinate technical, regulatory and validation batches at site.
• Support Validation Lead / Validation Expert in creation of validation protocol and report.
• Perform technical feasibility assessment for supply point decision in close collaboration with other stakeholders. Determine scope / design of technical batches for transfer.
• Establish site project plan, elaborate scientifically sound technical strategies with project team, develop contingency plans, identify hurdles and propose solutions. Assess and plan site resource needs and get management approval for the overall project costs (e.g. FTEs, batch costs, investments and external costs), strategies, and timelines.
• Form and lead site project team - set priorities for project and project team meetings, coordinate project team activities, ensure that Novartis guidelines and HSE and GMP guidelines are met.
• Ensure timely availability of technical documentation according to Novartis guidelines. Write Manufacturing Process Transfer Documents (protocol, report).
• Review key documents and coordinate input for relevant registration documents for accuracy and completeness (as appropriate).
• Liaise with global project manager, giving site (CMC team for development transfers) and site functions. Ensure knowledge transfer from giving site to receiving site including to operators.
• Accountable to coordinate inter-functional evaluation and implementation phases of change requests related to Drug Products
• Scientific Degree.
• Previous solid experience in a similar role within the Tech Transfer / MS&T / QA / Production department of a GMP environment.
• Fluent in Italian and English.

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Functional Area Technical Operations

Job Type Full time

Employment Type Regular

Shift Work No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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