Santosh Mustelwar

WORK HISTORY

EDUCATION

SKILLS

ABOUT SANTOSH MUSTELWAR

Pharmaceutical Executive with 20+ Yrs of extensive experience in development strategy for broad range of Analytical development and diversified product development in ADV’s,Innovator and Generic Drug space.Strong technical knowledge of Antibody drug conjugates,Drug substance, complex Injectable formulations, Topical formulations, Inhalation formulation (MDI & DPI), solid dosage forms; immediate release and modified release tablets and capsules.Developed various analytical methods like In-Vitro dissolution, Assay and Related substances and other testing procedures for various dosage forms like Solid oral, Semi solids, Parental, Liquid oral & Inhalation (MDI & DPI) for ANDA and NDA submissions. Expertise in characterization of inhalation dosage form (MDI & DPI) by developing various analytical methods like aerodynamic particle size distribution by using Twin stage impinger and next generation cascade impactor, Content uniformity by DUSA, Spray view and spray pattern by using Sympatec.Gained extensive experience in managing analytical outsourcing operations at CROs/CDMOs, Analytical activities for technical transfers, process validation, and cleaning validation.Rich experience in current Good Manufacturing Practices (cGMP) requirements & In Compliance with 21 CFR. Strong background in preparation of SOPs, STPs, GTPs and method validation/transfer protocol and report. Experience in OOS/OOT Investigation and report preparation.Efficient in multi-tasking and adapting exceptionally to any complex working environment, leading to the good results throughout the product development process, routine release, stability and highly conversant with laboratory software.