Experience

Cormedix Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Sr. Vice President: Head of Technical Operations

  • Jan 2023 - Present

• Vice President - Technical Operations (CMC)

  • Feb 2022 - Jan 2023



Jubilant Pharma Limited

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Director, Scientific Affairs & Innovation

  • Sep 2020 - Feb 2022

  o Responsible for building the innovative product pipeline and LCM strategy via 505B2 strategy. o Developing drug delivery platforms utilizing company’s current capability in the area of LA injectable and innovative dosage form design with unique advantage to PK. o Managing a team of 10+ formulation/analytical scientists for Radiopharmaceutical development. o Establishing best-practice for pharmaceutical product development across the R&D centers for the company which will ensure robust development and in compliance with the FDA guidance. Show less



Tris Pharma

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Vice President (Head), Research & Development

  • Jan 2020 - Aug 2020

  o Leading a team of 30+ formulation and analytical scientists towards achieving company goals for on-time high-quality filing (p-IND meeting package, 505B2, OTC and ANDA) and on-time launches.o Planning and managing R&D budgets in co-operation with finance group to ensure critical spending and investments. o Working with several clients on co-development projects for clinical manufacturing and supply of early prototypes. Responsible for managing relationships and transparencies. o Main point of contact for IP strategy and any litigation issues.o Transforming a small R&D organization to a more structured R&D organization by defining goals and objectives, creating job descriptions and training curriculum, spelling out roles and responsibilities.o Strategizing company’s talent acquisition and talent retention approach by building a rewarding environment. Show less

• Senior Director (Head), Research & Development

  • Apr 2017 - Dec 2019



New Jersey Institute of Technology

• United States
• Higher Education
• 700 & Above Employee

• Adjunct Professor

  • Jan 2012 - Dec 2019

  Teaching graduate course titled "Development and applications of drug delivery systems" Teaching graduate course titled "Development and applications of drug delivery systems"



Sandoz

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director (Head), Scientific Affairs

  • Oct 2015 - Apr 2017

  o Work directly with a cross-functional team from across BD&L, Reg. Affairs, QA and Clinical Dev. to evaluate CMC aspects of new product acquisition and in-license opportunities (total value: >500M). o Responsible for supporting technical due diligence with comprehensive expertise in the chemical, analytical and formulation development of pharmaceutical products and medical devices being considered for in-licensing.o Directed a team of 17 associates and ensured successful manufacturing process and analytical method transfer to the manufacturing studies or third party manufacturer.o Ensured QbD principles are followed during development and tech transfer, critical process parameters are identified. o Responsible for close-out of US SDC at East Hanover through decommissioning of the lab equipment, surrendering DEA and GMP licenses under an extreme tight timeline.o Responsible for TGT and LF2 budget for the development as the cost center manager. Show less

• Associate Director, Product Development

  • Mar 2014 - Sep 2015



Bristol Myers Squibb

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Principal Technical Investigator

  • Nov 2011 - Feb 2014

  I have led cross-functional team as project manager (product champions) to build product robustness monitoring plan (CPV) as a part of operational excellence and analyzed trends and criticality in product /process/equipment performance and ensure processes are and remain in a state of control. Extensively conducted product and process risk assessments (FMEA), collaborated with research and development in drug product process development of oral solids and non-sterile liquid dosage forms. I have been recognized by my company as an individual to support and build a rigorous global investigation program capable of 100% root cause analysis. In addition, I also significantly contributed to the organizations quality risk management processes throughout the product life-cycle. I supported technology transfer to the manufacturing sites within and outside BMS using principles defined in ICH, FDA, and other regulatory guidelines and ensured QbD principles are followed during development and tech transfer, key process parameters are identified, and appropriate monitoring programs are in place. I worked as a part of the operational excellence team to evaluate and set requirements for Process Analytical Technology (PAT) that enables the product control strategy. As a part of my current role, I supervised scientists to provide adequate mentoring towards problem solving. Show less



McNeil AB i Helsingborg

• Sweden
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Staff Scientist

  • Jul 2008 - Nov 2011

  o Executed several process validation campaigns to support on-time launch of the products (oral solids and liquids, chewable, ODT, topical ointments and stick) to meet seasonal market demand. o Managed multiple projects through cross-functional excellence and innovative ideations to support base business. o Well trained in R&D NOEs, investigations and tracking system: Trackwise® to support quality and compliance. o Actively involved in risk based management and CAPA systems to sustain routine productions. o Developed controlled-release formulation successfully for clinical studies (PK and efficacy) under a tight time-line to meet the seasonal period. o Reviewed and approved quality documents such as clinical study protocols, clinical manufacturing records (in-house and third party) and product specifications from R&D. o Prepared and approved CMC sections for submissions such as IND, CTA and sNDA. o Conducted “Consumer study” for understanding market needs for a typical product. o Implemented innovation from product development to cost saving to process improvement. o Designed and executed ICH stability studies and written reports. o Supervised associate scientists for study directions which effectively resulted in quick turnaround. Show less



Schering-Plough Research Institute

• United States
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Scientist

  • May 2005 - Jul 2008

  o Process Development  Designed and applied QbD principles and executed process characterization study to understand the effects of process parameters on drug products attributes.  Designed and executed scale-up activities for unit operations e.g., fluid-bed granulation and drying, high shear granulation, milling, blending etc.  Developed Process Analytical Technology (PAT) methods using NIR technology for granulation and blending unit operations.  Awarded with “Pharmaceutical Science Excellence Award” for 2008.  Authored “Development Practices for Powder Blending” for Pharmaceutical Sciences. o Formulation Development  Authored “Best Practice for Formulation Development” for Pharmaceutical Sciences.  Conducted Phase I novel formulation development to resolve solubility issues and subsequent optimization for NCE.  Collected and analyzed data such as stability, in process to evaluate different prototype formulations and method of preparation. o Communication • Authored and reviewed experimental protocols, technical reports such as “commercial formulation development report” and manufacturing batch records. • Presented study design and summary data to higher management. Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Scientist II

  • Jun 2002 - Apr 2005

  o Process Development  Responsible for manufacture of pre-validation and/or demonstration batches designed to assess critical process parameters and optimize processing conditions for all associated unit operations.  Responsible for manufacture of validation batches prior to commercial manufacture. o Formulation Development o Designed and executed experiments to optimize prototype formulations and associated process unit operations e.g., wet/dry granulation, drying, milling, compression and coating. o Responsible for packaging of early formulations and initiating and monitoring stability programs. o Communication & People Skill  Performed data collection and analysis, discussed conclusions regarding progress of work, and effectively communicated information to supervisor in the form of discussions and reports.  Authored and reviewed Investigational Clinical Production Directives, Specifications, and Technical Reports.  Responsible for preparation/execution/review of batch production records and supervision of technicians to support manufacture of feasibility (scale-up) batches.  Responsible for coordinating the activities of numerous functional groups (analytical, dissolution, physical testing, microbiology, stability services, documentation and experimental packaging) in support of project objectives and timelines.  Evaluated project outcomes and presented oral and written summaries to senior management.  Contributed to the preparation and review of the CMC sections of NDAs.  Prepared and reviewed documentation to support tech transfers and PAI. Show less



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Summer Intern

  • Jun 2001 - Aug 2001

  o Worked on the project tiled “Effects of Physico-Chemical Properties & Sub-Coating on Drug Release Rate of SR Pellets”. o Worked on the project tiled “Effects of Physico-Chemical Properties & Sub-Coating on Drug Release Rate of SR Pellets”.