Senior Research Associate

  Medical Writing

Job title: Senior Research Associate

Company: Piramal Capital & Housing Finance

Job description: Job Description This position has the primary responsibility for formulation development. The position is responsible for Pharmaceutical Research and Development (Literature search, Develop Plan, coordinate and manage/execute laboratory pharmaceutic

Job Description This position has the primary responsibility for formulation development. The position is responsible for Pharmaceutical Research and Development (Literature search, Develop Plan, coordinate and manage/execute laboratory pharmaceutical development, prepare technical documents) and assist the Technology Transfer of Injectable Drug Product on manual or automated platforms with high quality within time frame. Support Manager in Lab and EHS management Support Manager in Lab competency building. KEY ROLES and Responsibility: .Literature search, develop plan, coordinate and manage /execute laboratory pharmaceutical development activities in coordination with manager. .Show pharmaceutics proficiency and use advanced analytical techniques to develop drug product. .Perform complex experimental tasks including new techniques, procedures and equipment and propose experimental program and discuss with manager. .Data compilation, Prepare SOP and protocol, writing LNBs, perform routine equipment calibration and maintenance. .Prepare Product development report and other technology transfer related documents. Interact and support cross functional team such RA, QA and clients .Assist in smooth technology Transfer and or Scale-up of acquired or developed formulation products into and out of company .Support in preparation, technical evaluation of RFP, Customer Visits and Product Testing. .Prepare and review documents related to technology transfer such as protocols, reports, TTD and PDR, formulation related SOP&rsquos i.e. instruction manuals. .Develop, maintain, manage and document all research materials and data .Maintain inventory control of laboratory equipment and tools. .Interact with SCM department for ordering the materials.. .Comply with regulations concerning safety, health and environment .Assist lab leader in preparing presentation for project reviews, scientific reports preparations, literature search and data analysis Functional Skill / Competency .Strong Knowledge and understanding of the Pharmaceutical development and technology transfer with 2 – 6 years of industrial experience specially in sterile injectable products such as lyophilization and suspension etc. .Knowledge of Pre-formulation, Formulation Process Development for Europe, US & Japan market as well as for Domestic. .Well versed with Optimisation and Trouble Shooting using QbD Approach, Risk assessment .Preparation and review of – MFR, MPR, BMR, BPR, Reference formula document, Product Development Report and relevant SOPs. .Knowledge Reverse Engineering, PARA IV filing .Project Management (from initiation to commercial Production) .Knowledge of plant operations, and quality systems, ICH guideline, GLP & GMP with Desired knowledge of QA & Regulatory functions. .Very good ability to interpret data, draw conclusions, and present results. Sound Knowledge regarding formulation patents and patent issues .Technical writing skills. MS Office (Word, Excel & PowerPoint), Chemdraw and Internet Applications. Knowledge of SAP and other sourcing toolsQualifications QUALIFICATION: M. Pharma – Pharmaceutics EXPERIENCE: 4 -6 Year

Expected salary:

Location: Mumbai, Maharashtra

Job date: Fri, 04 Feb 2022 23:31:18 GMT

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