Technical Transfer Lead

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

Descrizione del lavoro

A global pharmaceutical company in Piemonte is seeking a Technical Transfer Lead to manage technology transfer activities at the site. The ideal candidate should have a scientific degree and significant experience in a GMP environment, leading cross-functional projects. Fluency in Italian and English is mandatory. Join a diverse team dedicated to improving patients' lives.

Competenze

• 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.

Mansioni

• Review and update Quality Risk Assessment prior to transfer.
• Define pre-validation/validation strategy including process.
• Form and lead site project team, ensuring compliance with guidelines.

Conoscenze

Leadership

Technical project management

Quality Risk Assessment

GMP compliance

Fluency in Italian and English

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.

Why Novartis : Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

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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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