394686BR
Mar 20, 2024
India
About the Role
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’s 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’s, 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.
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’s, 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.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we
achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
• Good presentation skills and scientific/technical writing skills.
• Good communication skills
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we
achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Development
TECHNICAL R & D GDD
India
Hyderabad, AP
Nov Hltcr Shared Services Ind
Research & Development
Full Time
Regular
No
