Job Description

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 patient\xe2\x80\x99s 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, SOP\xe2\x80\x99s, 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

Novartis