WN
Expert, Technical Development
wd3:novartis:novartis_careers
🇮🇳 India
On-site
10 hours ago
- GMP
- Technical Writing
- Waterfall
10 hours ago
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.
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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.
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Skills Desired
Materials Science, Process Simulation, Technical Writing, Waterfall ModelExpert, Technical Development · wd3:novartis:novartis_careers