Biotechnology - Oncology

• Manage injectable product development with external partners from due diligence to FDA submission.• Direct global multidisciplinary teams to develop sterile solution, lyophilized power and pre-filled syringes product from R&D development to manufacturing.• Provide technical due diligence for potential external acquisition by business development team.• Project management for timely completion of development and manufacturing activities such as negotiating contracts, batch manufacturing, stability testing.

• Led formulation and process development of injectable and ophthalmic products such as solution, suspensions, and lyophilized powder based on Quality by Design principles• Planned and executed all R&D studies to determine critical quality attributes and process parameter • Developed sterile formulation development capabilities; created standard operating procedures for efficient product development and resource optimization• Authored regulatory submission documents such as product development reports, in-process and finished product specifications, stability summary for FDA submission

• Led development of sterile injectable solution, lyophilized product, and ready-to-use solution. • Designed and executed formulation feasibility of anti-cancer and anti-fungal compounds for value-added NDA formulation. Evaluated various drug delivery systems for parenteral delivery.• Developed and optimized freeze-drying cycles based on Differential Scanning Calorimetry (DSC) and Freeze Dry Microscopy (FDM)• Designed and performed investigation and FDA deficiency studies to resolve submission issues. • Prepared FDA regulatory submission documents. • Worked in matrix team with scientists from Analytical, Quality Assurance, Project Management, Regulatory Affairs, Manufacturing and Tech. Transfer teams to ensure timely completion of development and manufacturing activities.

Developed and characterized Liposome formulation for anti-bacterial NCEsPre-formulations, Formulations and Solid state characterization - Orals and Parenterals.• Supported in-house formulation development of oral & parenteral dosage form.• Developed novel drug formulations such as nano-suspensions, solid dispersions, and liposomes for difficult to deliver compounds using nano-milling, spray drying, and lyophilization and analysed using UPLC/HPLC for pre-clinical PK, efficacy and toxicology studies.• Characterized NCEs for solid state/physical form screening (polymorphs, salts, amorphous dispersions) using solid-state characterization (DSC, XRPD, TGA, DVS) and selection of NCEs.• Designed and successfully executed pre-formulation and formulation studies (pH-solubility, pH-stability, drug-excipient compatibility etc.) to support drug discovery and development programs.

Coordinated and conducted the trials with medical specialists, organized many medical information symposiums in order to improve and develop the markets for infant milk formulations and cereals products.