Expert Science And Technology

Novartis India; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Novartis India is seeking a scientist to design, execute, and report analytical experiments for drug substances and products in a multidisciplinary team.

You will drive method development/validation, supporting regulatory compliance and data integrity with GLP practices, ensuring timely delivery of results and adherence to quality standards.

Qualifications

• Strong expertise in Chromatography and Dissolution Testing.
• Experience in Analytical Method Development, Validation and Transfer.
• Expertise in method validation, 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.

Responsibilities

• Design, plan and perform scientific experiments for DP/DS delivery within timelines.
• Develop, validate and transfer analytical methods and document results.
• Maintain GDP/GLP practices and ensure data integrity in LIMS or similar systems.
• Collaborate with project teams and ensure quality indicators are met.

Skills

Chromatography

Dissolution Testing

Analytical Method Development

Method Validation

Method Transfer

HPLC

UPLC

GLP Compliance

Regulatory Compliance

Education

M.Pharm./M.Sc.

Tools

GLIMS

Chromeleon

ELN

Job description

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.

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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