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Pharmaceuticals: Formulations, Injectables, Topicals, Analgesics, Pharmaceutical Analysis
CORE SKILLS Instrumentation skills. APIs/preformulation: X-ray diffraction; Raman spectroscopy; HPLC (potency, degradants, purity, linearity, accuracy, precision, LOQ, LOD) with detection via UV-Vis, fluorescence, and conductivity; content uniformity, dissolution/elution incl. sustained- and immediate release formulations, paddle wheel apparatus; forced degradation incl.…
Reaction Engineering, Process Reactor/ Technology Development, Design, Debottlenecking/ Revamp/ Upgrade, Modeling/ Application Software, Process Intensification
He is a recognized expert in design, development, scale-up, demonstration and debottlenecking of commercial reactors. With a track record of successful commercialization of three new technologies, currently working for a fourth, and zero-failure, he offers a unique set of capabilities…
Process Improvement, Virtual Process Validation, and Discrete Event Simulation
Expert possesses more than 25 years of experience working in industries of different segments (metal mechanic, polymers, rubber, automotive and machining). Combined with his depth of lean process experience, Expert has specialized himself planning and implementing new processes and performing…
Sterility Assurance Expert in terminal sterilization (Ethylene Oxide, Moist Heat, Radiation, Dry Heat) and Aseptic Processing to Medical Device and Pharmaceutical companies.
. Expert is President and Principal Consultant for his consulting company - a consulting LLC. Prior to going into consulting, he was Director of Corporate Quality Technology/ Sterilization Science, for Alcon a Novartis company where he was responsible for sterilization…
Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…
Protein aggregation, characterization, purification
Expert leads a team of exceptionally talented downstream scientists to develop scalable downstream processes for viral vectors for use in Gene, Cell and Oncolytic therapies and for Vaccine production and for therapeutics proteins and antibodies. Keywords: Process development, DSP, Downstream…
pharma, regulatory, cosmetics, biosimilars
The expert is having a post-graduate degree in pharmacy which is duly recognized by the University of Toronto and is currently working as Senior Regulatory Associate at the apex drug regulatory body in India i.e CDSCO. He is responsible for…
Process Engineering, Project Engineering, Project Management
Technical professional with process/product/project engineering and project management experience. Extensive experience integrating process design engineering with process engineering and R&D/product development to ensure success at both internal and contract manufacturing locations. Experienced with small to large-scale start-ups of processes and…
Pharmaceutical Formulation
Expert received his M.S. and doctorate in Pharmaceutical science from Long Island University, Brooklyn campus in 2017. During his doctoral dissertation, he worked on the rheological characterization of transdermal formulation and application of rheological models in product development and scale-up…
Combustion, Burner Design, Heat Transfer and Fluid Mechanics
Expert has worked in the field of combustion for over 30 years. Throughout this time, he has assumed principal roles in the design, development and commercial implementation of state-of-the-art equipment and processes for power boilers and industrial heating / melting…