Associate Expert Science And Technology

Summary

• Plan and perform scientific experiments (or pilot plant processes) for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures in collaboration within a multifunctional project team coordinated by a Project leader. Contribute to maintenance of lab instruments/infrastructure. -SANDOZ: Plan and perform scientific experiments (or pilot plant processes) for the development and timely delivery of drug products (DP), processes and procedures in collaboration within a multifunctional project team coordinated by a Project leader. Contribute to maintenance of lab instruments/infrastructure. -Support development projects aiming the development of stable, bioequivalent, robust and cost competitive dosage forms -Design and manage experiments/batches for simple/low complexity products under supervision, provide related scientific documentation -Plan and execute experiments in agreement with quality risk management and GDevP /GMP -Assists in the preparation of and reviews of the technological part of dossier
  
  

About The Role

• Key Responsibilities
• Plan, perform and document scientific experiments in the laboratory for drug substances (DS) and drug products (DP) in collaboration with multifunctional project teams. Contribute to maintenance of lab instruments/day-to-day operations. Timely execution of project related activities.
• Plan, organize, execute, and document scientific experiments (e.g., analytical method developments/ validations/ transfers/ stability/ release testing, formulation development analytics etc.) according to the agreed timelines and appropriate quality standards.
• Accountable for documentation and submission of raw data in appropriate data system (for e.g., LIMS test activation and results entry).
• Accountable for good documentation practices (GDP) and good laboratory practices (GLP) during execution of laboratory activities.
• Support in evaluation and interpretation of results including investigations on SST failures, OOX/Deviations/Change controls as needed.
• Responsible for implementation and maintenance of lean/efficient/environmentally sustainable practices in the laboratory.
• Proactively communicate key issues and any other critical topics in a timely manner to the manager and/or to any other relevant project team member(s).
• Responsible to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned activities.
  
  

Essential Requirements

• Strong expertise in Chromatography and Dissolution Testing, including method selection and handling
• Proven experience in Analytical Method Development, Validation, and Transfer
• Solid understanding of Regulatory Compliance and GLP standards
• M.Pharm./M.Sc. with up to 2 -5 years of relevant experience, with demonstrated experience in a related domain.
  
  

Desirable Requirements

• Understanding digital tools
• Hands on experience with GLIMS, Chromeleon and ELN
  
  

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? https://www.novartis.com/about/strategy/people-and-culture

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