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Nimesh Goswami
Senior Project Leader Pharmaceuticals Cmc @Apotex Inc.
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WORK HISTORY
Senior Project Leader Pharmaceuticals Cmc @Apotex Inc.
Miramar, FL, US
Pharmaceutical product and process development Manager at Apotex Pharamachem Inc. Technical service and post and pre-product launch and maintenance. Client service and subject matter expert for the formulation, process development, and product launch and post-approval life cycle management,• Provide technical and formulation assistance to the manufacturing of the Transdermal, Topical system and oral mouth dissolving film to commercial product support• Develop transdermal and oral film product and process from lab scale to commercial launch up to validation; incorporation of quality by design concept from the beginning of product development to life cycle management• Provide support internal R&D team to incorporate QBD concept (critical target product profile, critical quality attributes, critical material and process attributes, risk assessment, and life cycle management) from the beginning of the project to the end of the project up to submission.• Develop the strategy and collaborate with internal and external clients to support the supplement ANDA projects for product life cycle management and post-approval product changes. • Collaborate with external vendors, contract manufacturers, and customers to identify technical requirements and project timing and connect with internal departments to support and satisfy the need of the project in compliance with quality and good manufacturing standards.• Review and write the Development report, Cover letter, protocols, and other supporting documents for regulatory agencies• Provide responses to regulatory agencies related to the ANDA and supplement ANDA.• Develop the control policies and guidelines to support the formulation and process development also related to the process validation and technical operation.
EDUCATION
University
Doctor of Philosophy (PhD), Pharmaceutical Sciences
Gujarat University
M.Pharm, Pharmaceutical Development
Gujarat University
Bachelor of Pharmacy (B.Pharm.), Pharmaceutical dvelopment
ABOUT NIMESH GOSWAMI
Dedicated, Experienced, and accomplished pharmaceutical manager with over thirteen years…
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