Job Description 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. Execute the functional strategy and drive operational excellence in line with TRD vision and strategy. Ensure full portfolio support in line with GDD, Sandoz, NTO and NIBR plans.
Job Description
Major accountabilities:
- Independently plan, organize, perform and document scientific experiments /GMP testing /manufacturing plant activities under minimal supervision; handle several activities at a time -Take over responsibility for and utilize special tools /equipment or specialized facilities as an expert; schedule and perform maintenance and qualification of instruments / equipment -Proactively identify conflict situations and contribute to solutions -Work according to appropriate standards for quality, ethics, health, safety, environment protection, and information security; lead initiatives to ensure continuous improvement -Documentation of raw data, evaluate and interpret results; propose and actively support the design of next experiments.
- Review and verify raw data generated by others; approval of tests / experiments performed by others -Write protocols, scientific reports or lab procedures based on templates or SOPs under minimal supervision -For technical development units: Develop new methods or optimize existing methods/processes (lab or plant); contribute to development and implementation of new technologies -For GMP units: ensure compliance to cGMP -For technology-focused roles: Perform information and literature searches under minimal guidance.
- Actively foster knowledge exchange.
- Train and coach associate scientists, technicians, temporary employees and employees under training / education -For project-focused role: Participate in function-specific sub teams and fulfill assigned project tasks and responsibilities under supervision -Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
- Establish innovative solutions for verification and control of critical quality attributes, critical material attributes or critical process parameter in cooperation with other colleagues.
- Establish control procedures and specifications and review test procedures.
- Generate scientific documents to hand over to internal and / or external partners (e.g., MST, TechOps, authorities, external companies ) and support generation of international registration documents under minimal supervision.
- Report and present scie
- Reporting of 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:
- 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.
- SANDOZ: Senior Scientist:• Successful execution of assigned tasks and work packages• Successful interactions in project teams locally and across development network• Compliance with Novartis / Sandoz rules and guidelines• Positive feedback from leaders, peers, project team colleagues and peers from the networkScientist:Successful execution of assigned tasks and work packages• Successful interactions in project teams locally and across development network• Compliance with Novartis / Sandoz rules and guidelines• Positive feedback from leaders, peers and project team colleaguesAssociate Scientist: -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.
Skills Desired
Materials Science, Process Simulation, Technical Writing, Waterfall Model