Research Scientist- PD

SUMMARY OF THE OVERALL JOBTo undertake all activities related to initiation of projects in PD lab. To ensure all documentation related to tech transfer and SOPs relevant to PD. To initiate laboratory trials and necessary documentation for the same. To train, mentor and supervise the Research Associate for product development and documentation.Should be having experience in Bead mill and High Pressure Homogenizer operations.

KEY FUNCTIONS / RESPONSIBILITIESProject initiation activities:-To understand project timelines and required activities for the timely execution.To perform literature search required for idea generation form (IGF) upon receiving IGF.To review DMF received from suppliers.To prepare product feasibility based on IGF received.To create the item codes for material and procure material and Reference Listed Drug (RLD).To assist AD lab for Q1 Q2 estimation of RLD.To draft tentative specification for API, RM and finished good.To plan laboratory trials and stability batches.To finalize proposed manufacturing process.To initiate filter validation process with the filter supplier.To handle Bead mill and high pressure homogenizer.

Documentation:-To prepare tech transfer documents including MFR, BOM, Process flowchart, Critical process parameters and critical quality activities.To review product specifications, manufacturing documents.To prepare documents for trial batches.To prepare product development report.To prepare and review SOPs and prepare response for internal audits.To review documents related to filter validation.

Product Specification/ Tech Transfer/ CommercializationTo organize and execute trial pre exhibit and exhibit batches at plant.To execute first three commercial batches at plant.To provide technical support for existing commercial batch.To perform investigation of failures during exhibit batches/ stability (Out of Specification).InnovationTo come up with innovative and patentable formulations proposals.To come up with novel ideas which can reduce workload or expenses.Train, mentor and supervise RATo mentor RAs in planning the project activities in minute and actionable details.Help RAs in carrying out literature search.Help RAs in carrying out procurement of RLD, API and excipients.Plan and execute Knowledge sharing session for compatibility studies, reverse engineering, laboratory batches planning, filter compatibility, process optimization and recent updates in the field to emphasize importance of timeline adherence to team members.