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Hybrid Senior Expert Science & Technology

Novartis ·  Hyderabad (Office), United States Of America · Hybrid

  • Office in Hyderabad (Office)
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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).


 

Job Description

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.


 

Skills Desired

Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Model