Research Scientist

Role & responsibilities

• 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 equipments/ machinery and record keeping of usage and maintenance.

• Ensure compliance of SOPs, GLP, and GDP in product development of group Ideal Candidates

Preferred candidate profile