Responsible for drug product design, dosage form development of Oral and Parenteral formulations,technical support for drug products throughout the life cycle and some of the key activities includes: Develop formulation strategies for delivery of small molecules, Live-Biotherapeutic (LBP) agents, Peptide, PEGylated and Conjugated molecules. Provide expertise for CMC product development . Act as technical support to the formulation team and apply Quality by Design concepts in dosageform development. Understand regulatory requirements and apply science and risk-based regulatoryapproaches Perform investigations and problem-solving activities using appropriate root cause analysis techniques. Assist formulators throughout the product development. Support the development of high performing teams to deliver new capabilities. Work in collaborations with internal and external departments to generate intellectual property and sound scientific publications.

● Plan and lead formulation and manufacturing process development activities for early phase product development, develop enabling clinical formulations for early clinical phases.● Prepare simple formulations for oral and IV administration. Devise formulation strategies for solubility enhancement poorly soluble APIs e.g particle size reduction (Nanosizing), co-solvent, crystal modification and amorphous solid dispersions.● Develop radiolabeled API formulations (API in a bottle or filled capsule) and parenteral formulation for ADME studies.● Develop Modified Release (MR) Tablets and Capsule Multi-Particulates (MUPs) formulations. ● Author and review documentations for CMC activities and clinical doing.● Support manufacturing and process tech transfer from Pharmaceutical development to clinical batch manufacturing

Formaulation and Maufacturing Process Development for Oral solid dosage forms• Responsible for the formulation development of solid oral dosage forms. • Project work Experience: Managed and delivered S&T project involved knowledge transfer of extrusion process, wrote guidance documents such as risk assessments and user instructions. Lynparza Technology transfer support, formulation development of injection moulded polymeric controlled release system, and pre-clinical formulation development (immediate release tablet formulations) • Formulation and process development: Bioavailability and solubility enhancement of poorly soluble APIs using particle size reduction and solid dispersion platform technologies. Development of robust blending, milling, and compression processes to obtain final dosage form i.e Tablets.• Characterisation of material properties of drug substance and drug formulations to understand critical material attributes such heat capacity, true density, porosity, viscosity etc. Link critical material attributes (CMA) and critical process parameters (CPP) to critical quality attributes (CQA) such product properties, design, and performance. • Evaluation of flow (cohesion and adhesion) properties using shear cell, compression properties of drug substance and formulations using compaction simulator.• Process Analytical Technologies (PAT): Investigation of PAT (Micro-NIR) for blending to achieve homogenous blends, PAT tool involves the use of in-line NIR, UV and Raman probes. • Lead lab-based formulation and manufacturing activities, work closely with drug project delivery team and write guidance documents.

Investigations into developing a new composite for DENA's wood replacement products. The focus will be to develop a composite that will be physically stable. Involves the use of Hot melt extrusion and mechanical testings using Dynamic mechanical strength.

Investigation of Injection Moulding for Novel Drug Delivery Systems-Formation of amorphous solid dispersion using Hot melt Extrusion (HME) -Development of injection moulding (IM) process for pharmaceutical dosage form for controlled release application.Objectives:Molecular level dispersion of actives in polymer matrices using HME and IM processes. Solubility enhancement of BCS II drugs.Development of controlled release amorphous dispersion.

Project involved the study of interaction of formulation with skin barrier and understand the effect moisturizers on the diffusion drug molecule.Drug diffusion rate evaulated by Franz diffusion using Stratum corneum as barrier followed by HPLC analysis.Developmemet of semisolid dosage forms such as body creams, gel and shampoo formulation for treating Seborrhoeic dermatitis (SD)

Formulation & Development of Sterile dosage forms.- Parenteral formulations of pH dependent soluble molecules.- Ophthalmic dosage formsSpray dried dispersion Vitamine formulations