Job Description

Title: Manager-1

Date: Aug 26, 2022

Location: Tandalja - R&D

Company: Sun Pharmaceutical Industries Ltd

M.Pharm. (Pharmaceutics) with about 11 - 14 yrs experience in R&D product development with ophthalmic product development that includes liquid, suspension and also 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.

M.Pharm. (Pharmaceutics) with about 11 - 14 yrs experience in R&D product development with ophthalmic product development that includes liquid, suspension and also 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.