Aniruddha Deshmukh

Cmc Statistician - Discovery, Development and Manufacturing @Eli Lilly and Company

Bengaluru, IN

A) Roles and Responsibilities: Closely working with scientists/chemists/biologists from Drug Discovery, formulation scientists from Product/Substance Development and various Manufacturing personnel across geographic locations Work extensively on implementation of QbD, DoE, Risk Assessment, FMEA, PAT & GxP compliant Experimental design and analysis of analytical method development, validation and transfer Define Sampling plans with Acceptance Quality Limit and Probability of Failures Stability analysis & forecasting to inform development of clinical phase, sustainable specification, commercial specifications and expiry dating Development and implementation of novel methods to enable or advance drug development and manufacturing Collaborate with scientists and statisticians on applied research projects related to modelling, experimental design, process control, and/or multivariate analysis Author sections of regulatory (CMC – Chemistry, Manufacturing and Control) submission documents for successful product approval throughout the world Implement Statistical Process Control & Statistical Quality Control, with LEAN & 6-sigma methodology Collaborate with team members or even external partners to communicate development study results with an emphasis on visualization Regulatory Compliance: Perform work in full compliance with assigned curricula and responsible for following applicable Corporate, local, and departmental policies, procedures, processes, and trainingB) Training and Development: Develop and provide training courses for various statistical methodsC) Work Environment & Tools: R, Shiny-R, SAS-JMP, SAS, and many more.

Yashwantrao Chavan Institute of Science, Satara

Higher Secondary Certificate (+2)

Savitribai Phule Pune University

Master of Computer Management

Satara English Medium School, Satara

Primary and Secondary Schooling

New English School, Shrirampur (MH)

Pre-Primary and Primary Schooling

Shivaji University

B.Sc.(Statistics), M.Sc.(Statistics)