Job Description

• Experience in Formulation R&D product development with experience in injectable product development in Novel drug delivery systems/Lyophilized product/Solution product.
• To do literature search relevant to projects requirement and understanding of Regulatory guidance.
• To procure raw materials (API/excipients), packaging materials and Reference product in consultation with packaging/purchase department.
• To prepare request application for Testing/analysis license for new product/Reference product.
• To design, conduct pre-formulation and formulation developmental experiments with QbD approach and to enter the details about drug product manufacturing experiments in Lab Notebook.
• To prepare TR/IOM for the respective API/Excipients/product sample analysis.
• To prepare product development/stability study protocols and reports, prepare SOPs for related laboratory equipment/instrument and maintain critical data records for regulatory audits.
• To prepare document for Technology Transfer like sheet II, Master Formula, Risk assessment based upon CPP & CQA, FMEA and SDS.
• Group work for lab management, handling instrument, common group activities and co-ordination with cross functional teams for handling projects issue.
• To support cross functional activities at plant for Scale- up/ Exhibit batches/commercial batches and new assignments.
• Preparation of Product development report (PDR), Risk assessment reports and do compilation of project issues.
• To comply with the internal quality system while performing any activity.

Sun Pharmaceutical Industries