•16+ years of Scientific leadership and project management experience in Pharmaceutical Research and Development with leading global Pharmaceutical companies.• Developed & established team of Scientist to manage different portfolio of Oral Solids, dry powders, injections & infusions for Generics & differentiated Generics (US & EU market) from Lab scale research to commercial approvals.• Lead team for end to end technical gap analysis, Formulation Development & Process risk assesment for new products (complex generics) and site transfer products (alliances).• Demonstrated the leadership ability of managing R&D function internally & externally across the functional line globally.• Experience in fetching ANDA's, CBE30 & PAS filings. • Being certified QbD Professional, responsible for product development as per current regulatory norms.Rich Experience in,• Drug Delivery Systems/Dosage form- Nano-sizing (Nano-crystals), Nano-emulsions (SMEDDS/ SNEDDS), Multi-layer dosage form (IR and MR), Drug layering, Modified release technology, Dry powders for Suspension• Process scale-up- Granulation, Compaction (Roller compaction), Compression (Bi-layer), Wurster Coating. Establishing statistical process control (control charts, Cp, Cpk) and control strategy• Quality by Design- Application and implementation of knowledge of QbD principles. Technical risk assessment by different tools, PDD, Mechanism mapping, FMEA, Gemba. Experience of utilizing Design of experiments (DOE Stat-ease) for experimentation.• Regulatory documentation- Preparation & Review of module 3.2.p.2, technical write up for p.3, p.4 & p.5.6. (ICH Q8). Technology Transfer Document and query response.