Job Description

M.Pharm. (Pharmaceutics) with about 7 - 10 years experience in R&D product development with injectable product development that includes liquid, lyophilized and complex injectables.

• To have strong execution skills and to interact cross functionally and ensure timely submission and approval of the assigned projects as per agreed work plan.
• To provide the technical value addition throughout the development to achieve timely filing
• To conduct and review literature search and evaluate patent landscape for assigned project and work out the pathway for least time to effect successful submission.
• To perform pre-formulation and formulation development trials using QbD approach to develop a robust formulation.
• To manufacture batches for stability studies and analytical methods validation.
• To involve in scale up / exhibit batches execution at plant.
• To review Test Request reports for analysis of raw material (API / excipients) and Drug product.
• To write Laboratory Notebook to enter the details about drug product manufacturing operation.
• To prepare Development Study Protocol and execute the development study accordingly.
• To prepare and review Stability protocol to charge stability batches as per the protocol.
• To prepare and review Stability compilation sheet or development study report based on available COAs.
• To prepare and review Technology Transfer documents like Sheet II, MF, Risk Assessment based upon CPP & CQA, FMEA.
• To prepare Pre-IND /IND / NDA Package for regulatory communication.
• To prepare and set the in process and finished product Specification with scientific rationale.
• To prepare Product Development Report along with relevant back-up data for regulatory submission.
• To prepare and review SOPs related to laboratory equipment / instrument.
• To be a part of Equipment / Instrument Qualification activity in case of procurement of any new Equipment / Instrument and prepare and review qualification documents.
• To ensure compliance with the internal quality system while performing any activity.
• To timely respond FDA queries.
• To co-ordinate with cross functional departments like ADD, RA, CQA, Plant for project / product related activity.
• To be able to drive projects with internal and external stakeholders so as to meet the timelines.
• Provide novel solutions to simplify product development and develop robust products.
• To transfer projects successfully and troubleshooting if any with technical solutions so as to develop a product recipe that can be successfully manufactured post approval.

Sun Pharmaceutical Industries