Profile Details

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Hire Crystal P.

India

USD 50 /hr

15+ yrs of experience, Formulation Development specialist, P'cal Project Management, P'cal documentation

Profile Summary

• Exposure of working in core R&D centre to Contract based research organization. • QbD based Formulation Development of Oral solid NCE and generic dosage form (IR & MR) for US, EU, China and other markets. • Leads multiple projects, handled multiple CRO and clients as a project manager and formulation development manager • Working on data driven approach, customer based activities. • Thorough knowledge on US, Canada & Europe Guidelines, CFDA guidelines, ICH Guidelines, CTD documents • Designs experiments and carried our scientific work with an awareness of the state of the art technology which fits overall project objective. • Hands on Literature search, Documentation, DoE, Formulation development, Exhibit Batch manufacturing, Technology transfer, validation batch mfg., Project management. • Formulation and Optimization of Multi Unit Particulate System (MUPS) using Extrusion Spheronization and FBP, Bilayer tablet dosage form, Mini tablets, Tablet in Tablet technology, Tablet and blend in capsule dosage forms. • Hands on NCE-1 projects, FTM projects, NDA projects • Interpretation of Bio-study result. • Process selection, Optimization and strategy development and identification as per Stability and dissolution requirements. • Implementation of Management skills, scientific knowledge, experience, guidelines for robust product development. • Effective coordination, communication and Team player ability for smooth going of project. • Technical leadership, mentoring junior scientist to support the product development process • Hands on Project management software like Zoho and Alfresco • Effective project tracking through Gantt Chart • Effective coordination, communication and Team player ability for smooth going of project. • Flexes priorities to remain focused on objectives in rapidly changing circumstances. • Leading role in problem solving initiatives.

Subject Matter Expertise

• ☆ Pharmaceutical Technology
• ☆ Project Management

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Technical Writing

Research Feasibility Study, Fact Checking, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting

Product Development Formulation

Work Experience

Sr. Manager

Piramal Pharmaceutical

July 2015 - June 2020

Manager

Amneal Pharmaceutical

December 2009 - June 2015

Fellow Scientist

Glenmark Pharmaceutical

July 2005 - November 2009

Education

MBA

Gujarat University

July 2010 - June 2012

M.Pharma

Gujarat University

January 2003 - January 2005

Certifications

• Certification details not provided.