Expert science

2 days ago

Hyderabad, Telangana, India Novartis Full time

Job Description Summary 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 to support TRD-NCE strategies and goals.Job Description Major accountabilities: Plan, organize, execute, and document scientific experiments (e.g., analyticalmethod developments/ validations/ transfers/ stability/ release testing, formulationdevelopment analytics etc.) according to the agreed timelines and appropriatequality standards. Accountable for documentation and submission of raw data in appropriate datasystem (for e.g., LIMS test activation and results entry). Responsible for good documentation practices (GDP) and good laboratorypractices (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 assigned laboratory related area/activities (e.g.,chemical/reagents/consumables/samples/column/ glassware management etc.). Responsible for implementation and maintenance of lean/efficient/environmentallysustainable 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 performanceindicators) for all assigned activities. Support internal and external audits and ensure no critical findings within theassigned scope. Actively contribute to team and organization goals. Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISRM & NovartisGuidelines. Additional specific roles/tasks: See Up4 Growth training assignments for thebusiness roles for the associate as per the team matrix and completion of trainings in transcript of learning system (e.g., Up4 Growth). Minimum Requirements: Masters in Life Science (e.g., analytical / organic chemistry /pharmacy / pharmaceutical development) or equivalent. 5+ years of relevant work experience in OSD forms- hands on in chromatography, multimedia dissolutions, In-vivo & Invitro dissolutions, quality investigations, QBD etc. Fluent in English (oral and written). Knowledge of site language, if required. Knowledge in quality principles driving drug development such as GMP. Understanding of general regulatory and quality expectations. Good scientific background, communication skills including presentation and scientific/technical writing. Work Experience: Functional Breadth. Operations Management and Execution. Collaborating across boundaries. Skills: Environment. Experiments Design. Health And Safety (EHS). Laboratory Equipment. Manufacturing Process. Materials Science. Process Simulation. Project Management. Sop (Standard Operating Procedure). Technical Writing. Languages : English. Skills Desired Environment, Experiments Design, Health And Safety (Ehs), Laboratory Instrumentation, Manufacturing Processes, Materials Science, Process Simulation, Standard Operating Procedure (SOP), Technical Writing, Waterfall Model

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