Expert, Science & Technology

Novartis India; Hyderabad; On-site; INR 800,000 - 1,400,000; Full time

Job summary

Novartis India is seeking a scientifically skilled professional to design, plan, perform and report analytical experiments for the timely delivery of drug substances and products. The role targets robust chromatography methods, dissolution testing and method validation within a multi-disciplinary project team.

You will ensure documentation, adhere to GDP/GLP, manage data in LIMS/ELN, and support transfer/validation activities while maintaining quality standards and regulatory compliance.

Qualifications

• M.Pharm./M.Sc. with 4-8 years of relevant experience in analytical development or related domain.
• Strong expertise in chromatography and dissolution testing, with method development and transfer experience.
• Regulatory compliance and GLP/GDP knowledge required.

Responsibilities

• Perform method feasibilities and develop robust analytical methods for OSD/DP.
• Plan, execute, and document scientific experiments with appropriate quality standards.
• Document data in systems like LIMS/ELN and ensure traceability.
• Ensure GDP/GLP practices during laboratory activities.
• Support investigations, deviations, and change controls as needed.
• Maintain laboratory area and implement lean, sustainable practices.
• Communicate issues timely to manager and project team.
• Meet KPIs and support internal/external audits.

Skills

Chromatography

Dissolution Testing

Analytical Method Development

Method Validation

Regulatory Compliance

GLP

Education

M.Pharm./M.Sc.

Tools

LIMS

ELN

Chromeleon

GLIMS

Job description

Summary

Design, plan, perform, interpret and report results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures within a multifunctional project team coordinated by a Project Leader. Manage technical lab/plant activities. - Execute the functional strategy and drive operational excellence in line with TRD vision and strategy. Ensure full portfolio support in line with GDD: -Design, plan, perform, interpret and report results of scientific experiments for the development and timely delivery drug products (DP), processes and procedures. Lead and manage all project/local network activities.

About The Role

Key Responsibilities

• Responsible for performing method feasibilities and validation of robust analytical methodologies applied to innovative oral solid dosage forms. Strong experience in chromatography techniques and experience in handling techniques like Dissolution, Titrator etc., used for OSD testing is a pre-requisite.
• Plan, organize, execute, and document scientific experiments (e.g., analytical method developments/ validations/ transfers/ stability/ release testing, formulation development analytics etc.) according to the agreed timelines and appropriate quality standards.
• Accountable for documentation and submission of raw data in an appropriate data system (for e.g., LIMS test activation and results entry).
• Responsible for good documentation practices (GDP) and good laboratory practices (GLP) during execution of laboratory activities.
• Generate and support in evaluation and interpretation of results including investigations on SST failures, OOX/Deviations/Change controls as needed.
• Responsible for assigned laboratory related area/activities (e.g., chemical/reagents/consumables/samples/column/ glassware management etc.). Responsible for implementation and maintenance of lean/efficient/environmentally sustainable practices in the laboratory.
• Proactively communicate key issues and any other critical topics in a timely manner to the manager and/or to any other relevant project team member(s).
• Responsible to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned activities. Support internal and external audits and ensure no critical findings within the assigned scope.

Essential Requirements

• Strong expertise in Chromatography and Dissolution Testing, including method selection and handling
• Proven experience in Analytical Method Development, Validation, and Transfer and multimedia dissolution
• Expertise in method validation, method transfer, IcH guideline, HPLC and UPLC.
• Solid understanding of Regulatory Compliance and GLP standards
• M.Pharm./M.Sc. with 4 -8 years of relevant experience, with demonstrated experience in a related domain.

Desirable Requirements

• Understanding digital tools
• Hands on experience with GLIMS, Chromeleon and ELN

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

Benefits and Rewards:

Learn about all the ways we’ll help you thrive personally and professionally.

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