Dr. Moji Bonakdar ​

Dr. Bonakdar is a senior pharmaceutical sciences leader with strong experience in drug product development, Team Management, CMC and Regulatory. Has a keen interest in small molecules and proteins. Leading all development activities for ophthalmic, otic, sterile, and non-sterile, solid oral, drug products, drug/device, and medical devices. Currently working for United States Pharmacopeia (USP) since 2018) as Sr. Director, Small Molecules leading a matrix team of scientists responsible for all aspects of documentary standards product development.

Education: Moji has a B.S., Chemistry with minors in Math and Biology, Ph.D. Analytical Chemistry and Post-doctoral Analytical Chemistry. Moji has been ACS member since 1981 and has been with ACS career consultant since 2007 and the winner of ACS Career Consultants awards in 2018.

Specialties:
Global Head of Generic Drug Development: Leadership of multi-disciplinary pharmaceutical development teams, guiding activities resulting in filing, approval and launching of numerous drug products (25 ANDAs, 20 ANDSs and 10 MAAs). Demonstrated leadership ability in setting development, regulatory strategy, communication, and team-work skills. Leading all development activities. This includes Product & Process Development, Formulation development, back engineering of reference listed drug (RLD), Analytical characterization, Analytical method transfer, writing CMC documentation, technical review, filing regulatory submissions (ANDA, ANDS, MAA) and expert witness. Significant interactions with Marketing, QA, QC, Clinical, Regulatory, Analytical and Manufacturing plant teams.
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Pharmaceutical Development, Head of R&D Analytical Chemistry: Leading Analytical Chemistry Department Direct comprising 30 PhD and 20 MS and 25 BS scientists. Part of Leadership team of the Pharmaceutical Development Department (250 personnel). Responsibilities include guidance of directors and scientists, mentoring and training, resource allocation, performance evaluation, personnel development, promotion/succession planning, capital investments, and laboratory safety. Responsible for all aspects of analytical method development/validation, raw material characterization, stability studies, container/closure evaluation, Phase 3 clinical supplies testing, analytical method transfers to QC across the globe, writing INDs and NDAs sections. Manage issues, activities, budget, and resources through multiple governance structures.