Expert -Science & Technology

StrainX Biotech; Hyderabad; On-site; INR 1,500,000 - 2,700,000; Full time

Job summary

Novartis in Hyderabad is seeking a Senior Scientist to lead dissolution science and biopharmaceutics development for drug products. You will design and interpret experiments, drive mechanistic modeling, and collaborate across GMP labs to deliver robust processes.

You will advance regulatory strategies, maintain data integrity, and explore AI-driven automation to optimize workflows in a fast-paced pharmaceutical setting.

Qualifications

• Subject matter expert in dissolution science and biopharmaceutics for development and clinical specifications.
• Strong expertise in PBPK/PBBM modeling integrating dissolution and PK data.
• Proven track record in IVIVC/IVIVR approaches bridging in vitro data with clinical outcomes.
• Experience with mechanistic biopharmaceutics tools to address formulation challenges and regulatory strategies.
• Interest in AI-driven and digital automation solutions to enhance workflows.

Responsibilities

• Plan, perform, and document dissolution and biopharmaceutics experiments and related GMP testing.
• Develop and optimize methods/processes for drug product development in GMP/technical environments.
• Lead cross-functional activities and contribute to technical strategies within the project teamwork.
• Ensure compliance to cGMP and maintain instrument qualification and data integrity.
• Generate scientific reports and hand over data to internal/external partners as required.
• Support generation of regulatory documentation and registration dossiers with minimal supervision.

Skills

Dissolution science

Biopharmaceutics

PBPK/PBBM modeling

IVIVC/IVIVR

AI-driven analytics

Laboratory automation

Regulatory strategy

Education

PhD with 0-2 years of experience, or Master’s with 8+ years in pharmaceutical analytical development

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. -Management TrackLead a team for the development of pharmaceutical/biological/cell-gene therapies working in a small manufacturing plant environment. Execute the functional strategy and drive operational excellence in line with TRD vision and strategy. Ensure full portfolio support in line with GDD, Sandoz, NTO and NIBR plans. -SANDOZ: -Associate Scientist: Design, plan, perform, interpret and report results of scientific experiments for the development and timely delivery of drug products (DP), processes and procedures within a multifunctional project team coordinated by a Project Leader. Manage technical lab/plant activities. -Scientist: -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, support/coach team members, participate in sub-teams and contribute to overall SZ strategies and goals -Senior Scientist: Design, plan, perform -document and interpret scientific/developmental experiments and GMP testing or pilot plant processes for the preparation and timely delivery of generic products, processes or procedures; maintain and qualify equipment/infrastructure and manage operational aspects in lab or plant as assigned.

About The Role

Key accountabilities

Independently plan, organize, perform and document scientific experiments /GMP testing /manufacturing plant activities under minimal supervision; handle several activities at a time -Take over responsibility for and utilize special tools /equipment or specialized facilities as an expert; schedule and perform maintenance and qualification of instruments / equipment -Proactively identify conflict situations and contribute to solutions -Work according to appropriate standards for quality, ethics, health, safety, environment protection, and information security; lead initiatives to ensure continuous improvement -Documentation of raw data, evaluate and interpret results; propose and actively support the design of next experiments.Review and verify raw data generated by others; approval of tests / experiments performed by others -Write protocols, scientific reports or lab procedures based on templates or SOPs under minimal supervision -For technical development units: Develop new methods or optimize existing methods/processes (lab or plant); contribute to development and implementation of new technologies -For GMP units: ensure compliance to cGMP -For technology-focused roles: Perform information and literature searches under minimal guidance.Establish innovative solutions for verification and control of critical quality attributes, critical material attributes or critical process parameter in cooperation with other colleagues.Establish control procedures and specifications and review test procedures.Generate scientific documents to hand over to internal and / or external partners (e.g., MST, TechOps, authorities, external companies) and support generation of international registration documents under minimal supervision.

Essential Requirements

Subject matter expert in dissolution science and biopharmaceutics, with extensive experience in developing biorelevant and discriminatory dissolution methods to support formulation development and clinically relevant specifications.Strong expertise in PBPK/PBBM modeling, integrating dissolution, physicochemical, and pharmacokinetic data to predict in vivo performance and support model-informed drug development.Proven track record in establishing and applying IVIVC/IVIVR approaches to bridge in vitro dissolution data with clinical outcomes, enabling formulation optimization and risk assessment.Experienced in leveraging mechanistic biopharmaceutics tools to address complex formulation challenges, support regulatory strategies, and enhance scientific decision-making.Strong interest in AI-driven and digital automation solutions, with a focus on leveraging advanced analytics, predictive modelling, and laboratory automation to enhance efficiency, generate data-driven insights, and drive innovation in dissolution and biopharmaceutics workflows. Experience or demonstrated interest in this area is preferred.Ph.D. with 0-2 years of relevant industry experience, or Master’s degree with 8+ years of experience in pharmaceutical analytical development.

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.

Read our handbook (PDF 30 MB)

Seniority levelMid-Senior level

Employment typeFull-time

IndustriesPharmaceutical Manufacturing