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Literature search, Idea generationand preparation of technical reports.
• Preparation of product development strategy – keeping in mind technical, IP, regulatory & clinical requirements – for a variety of sterile drug products.
Screening & selection of raw materials (APIs, excipients, packaging components)
• Pre-formulation & solution chemistry studies
• Process development & optimization – complex injectable development
• Stability evaluation a pplicability of QbD principles in product development
Basic physico-chemical testing and u nderstanding of regulatory framework pertaining to product development &
filing (ICH, regulated markets)
Handling of technology transfer batches and submission in regulated market
• Following GDP, cGMP, GLP & laboratory safety practices during work.
Multi-tasking capability along with ability to think out-of-the-box.
Good interpersonal skills, effective verbal & written communication skills
Literature search, Idea generationand preparation of technical reports.
• Preparation of product development strategy – keeping in mind technical, IP, regulatory & clinical requirements – for a variety of sterile drug products.
Screening & selection of raw materials (APIs, excipients, packaging components)
• Pre-formulation & solution chemistry studies
• Process development & optimization – complex injectable development
• Stability evaluation a pplicability of QbD principles in product development
Basic physico-chemical testing and u nderstanding of regulatory framework pertaining to product development &
filing (ICH, regulated markets)
Handling of technology transfer batches and submission in regulated market
• Following GDP, cGMP, GLP & laboratory safety practices during work.
Multi-tasking capability along with ability to think out-of-the-box.
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Good interpersonal skills, effective verbal & written communication skills
PhD with 2-3 years experince
Public Indian pharmaceutical company developing and manufacturing generics, specialty medicines, biosimilars, and APIs for patients worldwide.
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Entry · 2+ years experience
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