Manisha Panda Email & Phone Number

Currently working as formulation scientist in Dr Reddy’s Laboratories in complex injectables, with immense interest in gaining comprehensive knowledge in the science and regulatory requirements for the product development.Enthusiast in applying them to get the product from bench to market.Key Responsibilities:- Literature & patent research.-pre-formulation studies and lab trials.-Formulation of complex generics(Q1/Q2) like liposomal formulation, ready to use injectables, lyophilised products, 505 b2 formulation for domestic and regulated markets.- Understanding on pre-clinical prerequisites with animal handling.-Formulation and process optimisation with QbD( like identifying and evaluating QTPP, CQAs).- Product design and understanding critical material attributes.-- Identifying and assessment of Risk matrix in a formulation and adopting control strategy for process optimisation.-Preparation of technical documents for exhibit batch execution like MFR, PIS, BMR , Risk assessment documents etc- Process understanding at large scale manufacturing/exhibit batches with exposure to plant production.-Preparation of PDR-population Bio equivalence studies as per product specific guidances -Clinical and pre-clinical studies for complex generics as per regulated markets-Stability studies as per ICH Q1 guidelines-Coordination and support to analytical team on sameness studies like Cryo-TEM, DSC etc , logistics teams for procurement , budget alignment.- Very enthusiastic in following-up activities and supporting cross functional teams to deliver good product on time .- Preparation of Test licenses,import licenses, BENOC etc-Clinical studies Other :--Apart from technical knowledge, I have experience in animal handling and fair knowledge of pharmacology on repurposing of drugs in my Bachelors-Have done project in formulation of Lipid- polymer based Nanoparticles in Masters. - Basic level of java & C++