Job description: 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 like Summary based approval (SBA), Patent reviews, research article relevant to projects requirement and understanding of Regulatory guidance. To design, conduct pre-formulation and formulation developmental experiments with Quality by Design (QbD) approach and to enter the details about drug product manufacturing experiments in Laboratory notebook. To prepare product development protocols, stability study protocols and reports, prepare SOPs for related laboratory equipment or instrument and maintain critical data records for regulatory audits. To prepare document for Technology Transfer like Master Formula, Risk assessment, Failure mode effect analysis and Safety data sheet. To support cross functional activities at plant for Scale- up/ Exhibit batches/ Commercial batches for assigned projects. Preparation of Product development report (PDR), Risk assessment reports and various project reports compilation. Profile description: .
