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 environments 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 environment and diverse team representative of the patients and communities we serve.

Accessibility and Accommodation

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
- Read our handbook (PDF 30 MB)

D

📌 Statistics & Process Analytical Technology Expert (Hyderabad)
🏢 Novartis
📍 Hyderabad