MOHAMMED ZAFAR IQBAL

Pharmaceutical Research & Development executive with extensive experience in managing diverse teams and achieving strategic development goals. Successfully commercialized over 15 products and filed numerous NDAs and ANDAs, contributing significantly to revenue growth through innovative drug delivery systems and efficient operational practices.

• Member of the American Association of Pharmaceutical Sciences (AAPS)
• Member of the American Chemical Society (ACS)
• The Pharmacists Society of the State of New York (PSSNY)
• Member of Bangladesh American Pharmacist Association (BAPA)
• Member of Bangladesh Pharmaceutical Society (BPS)
• Member of Pharmacy Graduate Association (Bangladesh)
• Registered (Licensed) Pharmacist (Bangladesh)

• Global R&D Leadership
• People Management
• Time Management
• CGMP and its implementation
• Film coating Technology
• Tablet technology
• Process & Cleaning Validation
• QbD, QOS, DOEs
• Win working in Matrix environment
• Finance for non-finance managers
• Marketing Management
• Manufacturing Technology
• People development
• Production Planning
• JMP statistical software
• Technical training at Glatt, Colorcon, Natoli, Evonik

• Formulation, Process engineering, Scale-up and technology transfer
• Oral Solid Dosage Form (Complex IR & ER formulations)
• Semi solid dosage forms
• Transdermal system
• Sublingual film, Bio-Erodible Muco-Adhesive (BEMA)
• Sublingual solution
• Vaginal drug delivery
• Well familiar with all Pilot & commercial process equipment for oral solid, semi solid, transdermal system, vaginal delivery and oral sublingual film manufacturing
• Invented a novel sampling thief that was used to collect blend samples without causing the segregation of the blend during insertion of the thief into the powder bed
• Invented vacuum assembly box to integrate different layers of a transdermal system to avoid human contact and hence minimize microbial growth.
• Well versed in SOP, GMP, GLP, Analytical aspects of formulation & Process development
• Statistical Analysis
• Biopharmaceutics
• IVIVR & IVIVC
• Project management
• Strategy development to win First to File projects
• QbD, DOE, QOS, PDR and FDA's deficiency letter response
• Designed established Pomona R&D Pilot plant for oral solid, semi-solid, transdermal & oral thin film

• Headed R&D Formulation, Process Engineer, Technical Services and Pilot Plant team.
• Streamlined the planning and execution process to enhance outcome
• Leadership, people influence and development
• Technology leader, responsible to bring new technology to the site
• Led the team responsible for planning and execution of R&D experimental and ANDA batches at various commercial sites
• Led the team responsible for budgeting and managing the cash-flow for the capital expenses for equipment procurement and facility extension & modification
• Established a team of highly motivated and enthusiastic formulation & process scientists with remarkable working relationship within themselves and with other cross functional teams and supports.
• Organized trainings to bring the scientists up to date with all the recent changes in Qbd, DOEs GDUFA and new stability requirement imposed by the Agency. Team members were motivated to each other so they are successful as a team.
• Worked with McKinsey & Company, the world's top management consulting firms for over three months looking into various ways each three R&D site (Pomona, Zagreb & Israel) and found ways and recommended as how to increase the number of submissions per site for Pomona, Zagreb & Israel site with the existing infrastructure. The recommendations were implemented which resulted in over 35% increase in R&D performance.

• "Enhance solubility of poorly soluble drug candidates"
• "Technology Platforms for Amorphous Solid Dispersion"
• "Multiarticulor dosage form The most versatile drug delivery platform for Oral Solids"
• "The competence and Intricacies of Fluid Bed Technology"
• "Effects of drug-carrier interaction on Drug Dissolution from Binary and Ternary Matrices"
• "Effect of plasticizer on Heat Capacity drug and solubility from drug polyer carrier matrices"
• "Equation to predict the drug solubility from a ternary solid dispersion"
• "Change in polymeric homogeneity on film application for a multiphasic transdermal system"
• "Comparison of the Performance of Two Sampling Thieves for the Determination of the Blend CU"
• "Process Scale-Up Guideline Based on Quality by Design Principles"
• "Quality by Design Principles a paradigm shift in formulation development"
• "Role of various knife design and temperature controls on the coating performance on the film for the transdermal drug delivery system"
• "Micronutrients as Therapeutic Agents"
• "Amiodipine in the Management of Hypertension"
• "Role of Ciprofloxacin in the Management of Diarrhea Diseases"
• "Intricacies of operation excellence"
• "Diagnosis of R&D operation excellence & improve efficiencies"
• "Fluid bed palletization systems: CPS& and Wurster technologies" presented in the World Delivery and Novel Therapy Summit in Toronto, Canada in 2018
• "Essentials and Intricacies of Wurster HS Fluid-bed Coating"
• "QbD A paradigm Shift in Drug development"