Siddharth Mahajan Email & Phone Number

Hyderabad, Telangana, India

Hyderabad, Telangana, India

Hyderabad Area, India

Regression modeling, process capability and robustness analysis, stability data trending, specifications and release limits, data extraction from SAP database, Technical documentation, technical support for international manufacturing sites and stability centers. Provide support to stability centers and manufacturing sites in data handling; drafting and review of technical documents; data trending; and statistical evaluation.Managing service and accounts from associates from quality and manufacturing sites sitting at various global sites.• Project: Predictive model to analyze CQA prior testing for Release and Stability. Lead a team of 3 members, involved in conceptualizing and preparing a POC for a predictive model for stability data, which can be used for scheduling and planning for stability centers across Novartis with help of a simplified dashboard using QlikSense.• Project (Green-belt) - Improving the Customer Satisfaction for Statistical and Analytical Monitoring Service, where the customer satisfaction was increased from 4.5 to 4.9 and showcased a saving of $100k.• Onboarding of 2 new services worth 4 FTE in 2019. Onboarded of 2 new services (Excel validation for Stein Solids/GV and Stability report writing for Broomfield), since March 2019.• Project: Deployed Alteryx in stability report drafting, reducing manual effort by 25%.• Business Continuity Management coordinator for complete practice.

Bengaluru Area, India

Five years of biosimilars (CMC) process development, identifying correlations between PPs, QAs and CQAs and technology transfer to Pilot lab and Manufacturing plant. Successfully developed process steps for biosimlar product (protein purification, enzymatic conversion, crystallization and freeze-drying) followed by technology transfer to manufacturing plant.• Scale down model qualification (SDMQ), failure mode and effect analysis (FMEA) followed by process characterization and linkage studies to identify the PAR (proven acceptable ranges) for the PP (process parameters)• Specific expertise pertains to cation exchange chromatography, enzymatic conversion of peptide precursor molecules, crystallization and freeze drying of in-process and final product.• Statistical driven design, analysis and risk assessment for the selection of critical process parameters (CPPs).• Designing univariate/multivariate experiments for identified CPPs and model building.• Process validation - Verifying compliance to control strategy (Process characterization outcome), identification of requirement, study design and reporting the outcome.• Continuous process verification (CPV)• Process deviation - Hypothesis testing, root cause identification and CAPA proposal• Regulatory support - CMC readiness and IR responses• People Management

Bengaluru Area, India

Bengaluru Area, India

Master'S Degree, Biotechnology

Bachelor Of Technology (B.Tech.), Biotechnology