Milan Vasoya Email & Phone Number

Vadodara, Gj, In

Vadodara, Gujarat, India

Responsible for end to end development of complex generics 505 (b2)& ANDA projects which includes Formulation development using statistical approaches, Patent protection, Technology transfer and Regulatory supportSIX SIGMA BLACK BELT-Leading team of 3- Working on Sun Pharma's Innovative concept of cytotoxic drugs in Infusion Bag- Project portfolio also includes Ready to use emergency medications including peptides-Working towards innovative patent protected formulation development-Responsible for Document preparation of Project planning and tracking Process Capability Analysis Shelf life prediction, QTPP, FMEA, CMA, CQA, CPP, Elemental risk assessment, Extractables and leachables, Product development report, Technology transfer, Trouble shooting and Regulatory filing and query response -Applying various statistical tools for robust and quality product development which includes...1) Process capabilityNormal/Non normal distributionCp, Cpk, Pp, Ppk, 6 sigma(Zigma) 2)Measurement system analysis- Gage study, attribute agreement analysis3)Control charts4) Design of experiments- Fractional Factorial, Factorial, Response surface, Mixture5) RegressionSimple, multiple (Linear, quadratic and cubic)Stability analysis by regression6) Hypothesis testing-t-test - one sample, two sample, paired Standard deviation- One sample, two sample, standard deviation test. Anova-One way, two way, multiple7) Plots-Scattered, dot, Histogram, Box, interval, individual value, line, contour, surface, main effect, interaction, pareto

Bangalore

Responsible for--Development of Insulin and analogue biosimilar product and characterizing it using Design of experiments with Quality by Design Approach-Biologics Formulation and Process Development of Insulin,Insulin Glargine and Insulin Lispro (Soluble and Suspension)-Screening and Optimization of Important Quality Variables to Improve Quality of Product in terms of Critical Quality Attributes-Crystallization Optimization-Stability Studies of Different Insulin Formulations-Design of Experiments and finding out Design Space towards Quality by Design Approach-Formulation and Analytical Troubleshooting-Setting bio-similarity targets- Guiding subordinate for Development Studies

Hyderabad

Project work on "Application of Quality by Design Approach in Development of Stability Indicting Assay Method for Two Drug Combination" under the guidance of Dr Amit Khanna

Hyderabad

Development of Analytical Method using HPLC

Masters In Science (Ms), Pharmaceutical Analysis, 9.22 On A 10 Point Scale

-Worked with Chemometric techniques and Design of Experiments -Used softwares like Unscrambler, JMP, LC Solution, Design Expert, Chem draw.

B.Pharm, Pharmacy, Distinction

Presented review on "Stem Cells Regeneration" in the National Festival "FOOTPRINTS" at MSU

10+2, Science