Statistics and Process Analytical Technology Expert

Statistics & Process Analytical Technology Expert

Job Description Summary

#LI-Hybrid
Location: Hyderabad, India

Bring your expertise in advanced statistics to the forefront of pharmaceutical manufacturing. In this role, you will play a key part in applying state-of-the-art statistical and process analytical technologies to improve process understanding, strengthen product quality and compliance, and enhance overall efficiency and performance. Working both at site level and across the global network, you will help turn complex data into meaningful insights that directly support better decision-making and drive continuous improvement.

Job Description

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

• Apply statistical process control techniques to monitor trends and ensure ongoing process verification

• 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.

• Strong 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

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired

Applied Statistics, Change Controls, Data Analytics and Digital (Inactive), GDP Knowledge (Inactive), Good Manufacturing Practices (GMP), HSE Knowledge (Inactive), Manufacturing Processes, Manufacturing Production, Manufacturing Technologies, Operational Excellence, Process and Cleaning Validation (Inactive), Process Control, Quality Compliance, Regulatory Compliance, Resilience and Risk Management (Inactive), Technical Leadership, Technology Transfer

Experience Level

Senior Level