Senior Expert Science

2 weeks ago


Hyderabad, Telangana, India Novartis Full time

Summary 400 This is the number of associates in Global Analytical R D across 4 countries working tirelessly on innovative and patient centric medicines As part of this group you design plan and or perform scientific technical studies By bridging the analytical science to the clinical performance you will drive the transformation of our molecules into medicines that improve and extend patients lives The position is based in the Genome Valley Hyderabad within the Technical Research and Development Organization TRD of Global Drug Development GDD Your responsibilities will include but are not limited to Design plan and perform scientific experiments for projects at different clinical phases of drug substance and drug product with minimal guidance Well versed with regulatory guidelines scientific literature technology transfer and interpretation of the results to draw conclusions in reports Author review approve GMP documents eg Analytical methods raw data SOPs Qualification reports for analytical instruments Report and present scientific technical results internally and contribute to publications presentations and patents Adhere to Quality metrics Compliance and Good Documentation Practices following ALCOA principles GLP OQM HSE ISEC and Novartis guidelines Should be a Team player by adding value in collaborating with other teams to support project deliverables within agreed timelines mentoring new joiners active participation in project meetings networks meetings and contributing to Team goals while meeting individual objectives Ability to perform investigations guide team members communicate proactively and clearly to global stakeholders and handle multiple priorities Provide input into CMC documents to support regulatory submission and respond to HA queries Role Requirements Desirable knowledge of site language up to 12 years for M Pharma M Sc minimum of 6 years for Ph D experience in Analytical testing project management in NCE complex injectables peptides and late phase method validation Good presentation skills and scientific technical writing skills Good communication skills Skills Desired Coaching Skills Data Science Environment Experiments Design Health And Safety Ehs Laboratory Equipment Manufacturing Process Materials Science Process Simulation Project Management Sop Standard Operating Procedure Technical Writing


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