Research Scientist - I

Have working knowledge of lyophilized product development and transfer to plant. Have good knowledge on documentation practices with respect to preparation and review. Timely development and delivery of allotted formulations and any other assigned project as per agreed timelines and budget. Completion of document preparation and formulation activities to support pre-clinical, clinical supplies and technology transfer, exhibit batch manufacturing of developed product. Development of non-infringing strategies for novel formulations in compliance to regulatory requirements for US, EU, and ROW market. To write Lab note books, stability data compilation and tracking of project progress. To prepare BOM for new UID activities with respect to costing of NPDs. Preparation and request of spec for raw material, packaging material, in-process controls and finished product specification. Preparation / review of documents for manufacture exhibit / commercial batches like master formula card, product specifications, product development report and technology transfer docket and co-ordination with support functional team for timely delivery of projects. Identification of product / Process specific equipment's / machinery and record keeping of usage and maintenance. Ensure compliance of SOP's, GLP, and GDP in product development of group.