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NOVARTIS
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Senior Expert Science & Technology

Senior Expert Science & Technology

NOVARTIS

6 - 11 years

8 - 13 Lacs

Hyderabad

Posted:1 day ago| Platform:

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Skills Required

Networking Method validation Technical writing Pharma Analytical GLP GMP HSE Mass spectrometry Chromatography

Work Mode

Work from Office

Job Type

Full Time

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 s lives. The position is based in the Genome Valley, Hyderabad, within the Technical Research and Development Organization (TRD) of Global Drug Development (GDD).

About the Role

Major accountabilities:

Design, plan and interpret scientific experiments for projects at different clinical phases of drug substance and drug product development with minimal guidance. Well versed with regulatory guidelines, scientific literature, technology transfer and interpretation of the results to draw conclusions in reports.
Provide scientific guidance to the laboratory associates
Write, review and/or approve analytical documentation in timely and high-quality manner, such as releases, analytical batch records, method validations, stability, technical reports, SOP s etc. ensuring compliance with Novartis and health authorities guidelines
Helping to define the overall analytical control strategy
Contribution to scientific exchange groups within Novartis
Report and present scientific/technical results internally and contribute to publications, presentations, and patents
Manage interactions and contribute to a high level of collaboration with internal and external stakeholders.
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

PhD in analytical chemistry or equivalent and a minimum 6 years experience or M. Pharma/M. Sc with a minimum of 12 years experience in the pharmaceutical industry in analytical research and development
Experience in leading analytical activities in NCE across different phases of drug development, including complex injectables, parenteral, oligonucleotides/ peptides. Strong experience in various chromatography techniques is a pre-requisite. Experience in mass spectrometry applied to biological molecules would be an asset
Profound expertise in liquid chromatography separation techniques such as (RP, IEX and HILIC) is a must
Experience in Late phase method validation is an asset
Good knowledge of software and computer tools such as Office package, LIMS, chromatography data-evaluation software (e.g. Chromeleon) etc.
GMP experience in analytical laboratory
Successfully demonstrated expertise in a specific scientific/technical area
Good presentation skills and scientific/technical writing skills.

Benefits and Rewards:

Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

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NOVARTIS

Pharmaceutical Manufacturing

Basel Baselstadt

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Senior Expert Science & Technology