Tech. Steward - Project Support

Overview

Summary

Technical Transfer Lead : Responsible for technology transfer activities at site level (inbound and outbound), including any scale-up or other process adaptations. Leads technical transfer project team at site and liaises with involved functions (e.g. Technical Development, Supply Chain, Production Unit, Quality Control, HSE, other sites). Product Steward : Owns the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains oversight on process capability through data trending and statistical analysis of critical variables, ensuring processes are robust, in validated state and continuously improving. Ensures seamless flow of knowledge and information across functions and with other sites where applicable, provides second line technical / scientific process support. Technical Steward : Provides specialist SME knowledge of specific pharmaceutical processes or process technologies (e.g. galenics, film coating, biologics – upstream or downstream). Oversees processes and standards to maintain and improve existing and implement new innovative manufacturing technologies. Validation Lead : Develops, implements and manages the site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and budget. Senior Scientist MSAndT : Design, plan, perform, interpret and report scientific experiments to contribute to MSAndT strategies and objectives.

Major accountabilities

• Technical Transfer Lead - Review and update Quality Risk Assessment (QRA) prior to transfer and prior to validation; adapt control strategy if needed.
• Review first APQR after transfer to ensure adequate product performance; ensure all relevant technical information and documentation for validation is available.
• Define pre-validation / validation strategy including 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.
• Product Steward - Maintain oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to date; act as SPOC.
• Create and maintain a product-specific Quality Risk Analysis (QRAs).
• Monitor all critical variables and key variables using statistical analysis and data trending.
• Review APQR and decide on state of control.
• Technical Steward - Act as the SPOC for interface with global MSAndT network and with technical development organization to define and implement new technical standards for existing and new technologies and equipment.
• Own knowledge of specific pharmaceutical manufacturing process technologies locally, including pilot scale, scale up or down, and Design of Experiments (DoE).
• Provide technical expertise for validation activities around technologies within area of responsibility.
• Harmonize and optimize technical processes across the site.
• Validation Lead - Support Product Steward in maintaining the process control strategy.
• Provide technical expertise and facilitate establishment of Quality Risk Assessment as needed.
• Define and implement validation strategy (process, cleaning, ongoing verification) and defend to authorities.
• Overall responsibility for establishment, prioritization, execution and tracking of Validation Master Plan for process, cleaning, packaging validation and ongoing process verification (OPV), ongoing cleaning verification.
• Senior Scientist MSAndT - Manage complex projects with deep understanding of development process requirements; address difficult topics (e.g., new by-product investigations, complex deviations); support cross-product alignment; report technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt; distribution of marketing samples where applicable.

Key Performance Indicators

Minimum Requirements

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Languages

Why Novartis : Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people. Collaborating, supporting and inspiring each other. Joining to create breakthroughs that change patients’ lives. Visit Novartis careers page for more information.

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