Job Description

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