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@manishdudhani
Membre depuis le 20 septembre 2016
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manishdudhani

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Overall 14 Years of Experience in Pre-formulation and Formulation Development of New Chemical Entities and Generic product development across various Pharmaceutical Industries. High experience in development and validation of drug product. Good multidisciplinary background in different areas of the drug discovery from RnD and commercial. Specialties: [login to view URL] Development of New Chemical Entities for Late Stage Clinical Phase. [login to view URL] for NCE molecules Phase I, Phase II and Phase III [login to view URL] Development for First-in-Human Clinical dosing. [login to view URL] for Generic product development. [login to view URL] for overseeing all the technical aspects of development and manufacturing. [login to view URL] scale up and technology transfer. [login to view URL] development, validation and continous improvement. [login to view URL] testing [login to view URL] management. [login to view URL] of externa partners/TPC/CRO/CMO. Working toward lean sigma yellow belt certification.
$50 USD/hr
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Expérience

Technical Manager - ESO - MS&T

Jul 2013

Providing expert CMC and technical expertise whenever it is needed RA and evaluation risk of the CMO. Responsible for development and technology transfer of drug products from development to commercial scale Troubleshooting/investigations/optimization of existing commercial manufacturing processes. Process improvement Continous validation. Contract manufacturing Prelimininary Risk assessment of RnD and Commercial site, Investigator,CAPA, Change control,

Associate Manager - Drug Product Development

Feb 2010 - Jul 2013 (3 years)

Design, execute, and interpret formulation and process development experiments leading to the development and optimization of various oral pharmaceutical forms and dds. Preformulation studies for NCE Development of Suspension, Capsule, tablets required for Phase I, II, & III [login to view URL] collaboration within international teams (Analytical, Manufacturing, Quality Control and Quality Assurance, Purchasing, Regulatory, Packaging, Suppliers of raw material

Associate Scientist - formulation

Nov 2005 - Feb 2010 (4 years)

New Product Development for [login to view URL] on CR / MUPS/Immediate release dosage forms. Products with suitability petition. Preparation of strategies and action plan for patent infringing and non-infringing formulation for ANDA. Preparation and compilation of Master Formulae Card. Preparation and compilation of Product Development report. Stability protocol for exhibit batches, finished products and regulatory specifications. Preparation of Specification and In-process specification.

Officer - Formulations

May 2004 - Oct 2005 (1 year)

Worked of ODT, Pelletization, compression, Extruder Spheronization technologyies.

Éducation

Master of Pharmaceutical Sciences - Industrial pharmacy

2001 - 2003 (2 years)

Qualifications

Operation Excellence Certificate (2012)

SSA limited

Certifications

  • US English Level 1
    88%

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