About this role
Job Description 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 Job Description
• 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
Skills Desired Environment (Inactive), Health And Safety (Ehs) (Inactive), Laboratory Instrumentation, Manufacturing Processes, Materials Science, Process Simulation, Standard Operating Procedure (SOP)