Posted 3w ago

Research Scientist III

@ Aveva Drug Delivery Systems
Hyderabad, Telangana, India
OnsiteFull Time
Responsibilities:manage formulation, develop solids, scale up
Requirements Summary:Pharma M.Pharm with extensive R&D formulation experience; solid oral dosage development; regulatory documentation; technology transfer.
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Job Description

1.0 Result-orientated professional with over 12-15 years of experience in managing research and development functions in formulation, mainly pellets formulation for regulated markets.



2,0 Expertise in the development of solid orals (IR, MR tablets) and liquid dosage forms for regulated ANDA (US) and EU markets.



3.0 Planning, preparing and compiling scale-up activities of products satisfying stability specifications; performing technology transfer of the optimized products at the respective location.



4.0 Improvising formulations, formulation optimisation, and process optimisation using QbD approach.



5.0 Taking stringent measures, including preparation of necessary technical documents, to ensure compliance with quality standards and customer requirements. Generating, reviewing and approving technical documents like MFR, MPR, BMR, BPR, Trade dress, Product Development Report (PDR), Stability study protocol, Hold time study protocol, in-use study protocol, alcohol dose dumping study protocol, Bill of Material (BOM) and relevant SOPs; implementing filing systems in relation to materials used for development of product.