Summary:
LI-Hybrid
Location: Hyderabad, India

About the Role:
Key Responsibilities
Lead statistical support for process validation and technology transfer activities across manufacturing operations
Perform statistical analysis to demonstrate process validity, consistency, and equivalence across products and sites
Design and evaluate experiments using Design of Experiments methodologies within quality by design frameworks
Perform stability data analysis and define scientifically justified internal release limits
Support root cause investigations through advanced data analysis and contribute to rapid root cause identification
Validate and transfer analytical and process analytical technology methods across manufacturing sites
Develop and implement multivariate data analysis models for process monitoring and control
Drive continuous process improvement through statistical modelling, hypothesis testing, and capability assessments
Build statistical capability across teams through training, coaching, and collaboration with global and regulatory stakeholders





Essential Requirements:
Master’s degree in Statistics, Mathematics, Chemical Engineering, or a related field.
Proven experience in MS&T; and manufacturing settings within biologics or large molecule (LM) setups.
Robust expertise in Data & Digital with a focus on applied statistics, including multivariate data analysis.
Solid understanding of GMP and pharmaceutical manufacturing processes, including regulatory requirements.
Experience in the following software and tools is a plus: SAS, R, Python, Minitab, SIMCA-P+, Modde, JMP, SPSS.

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work workplace and diverse team representative of the patients and communities we serve.

Accessibility and Accommodation

Perks and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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📌 Statistics & Process Analytical Technology Expert Hyderabad
🏢 Novartis
📍 Hyderabad