Expert Science & Technology

Summary

-Design, plan, perform, interpret and report results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures within a multifunctional project team coordinated by a Project Leader. Manage technical lab/plant activities. -Management TrackLead a team for the development of pharmaceutical/biological/cell-gene therapies working in a small manufacturing plant environment. Execute the functional strategy and drive operational excellence in line with TRD vision and strategy. Ensure full portfolio support in line with GDD, NTO and NIBR plans.

About the Role

Major accountabilities:

• Provide analytical and technical support to project teams at various stages of product development (eg. CSF, FMI and LCM).
• Design and author analytical documents (e.g., Analytical methods, Stability protocols/reports, Excipient compatibility (EC) protocol/reports; APS protocols/reports, etc.).
• Support Analytical project leader for setting analytical development strategy.
• Support in data interpretation, results compilations and sharing the information with critical observations and proposals to project team.
• Responsible for project related sample handling (e.g., sampling plans, issuance, storage, distribution, reconciliation/destruction of the samples).
• Support planning for assigned project activities. Accountable to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned project activities.
• Provide requests for lab activities to the associates and stakeholders.
• Manage project activities including logistics at third parties and external testing laboratories.
• Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s).
• Single point of contact for PHAD/CHAD/ARD and other stakeholders for project execution activities.
• Support internal and external audits and ensure no critical findings within the assigned projects.
• Actively contribute to team goals.
• Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC & Novartis Guidelines.

• Successful execution of assigned tasks within given timelines at expected quality; right first time and right in time -Adherence to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines -Adherence to costs, quality, quantity, and timelines for all assigned tasks.
• Feedback from other team members/leaders.
• Refer to annual individual and team objective setting.
• Measurable contributions to increasing efficiency and productivity in the work related to assigned projects.
• Feedback from other team members/leaders.
• Refer to annual individual and team objective setting.
• Measurable contributions to increasing efficiency and productivity in the work related to assigned projects.

• Functional Breadth.
• Operations Management and Execution.
• Collaborating across boundaries.

• Environment.
• Experiments Design.
• Health And Safety (Ehs).
• Laboratory Equipment.
• Manufacturing Process.
• Materials Science.
• Process Simulation.
• Project Management.
• Sop (Standard Operating Procedure).
• Technical Writing.

• English.