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Manager - Formulation Development - Biosimilar Injectable Drug - Pune

9.00 to 14.00 Years   Pune   26 Jan, 2023
Job LocationPune
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaR&D / Product Design
EmploymentTypeFull-time

Job Description

    Leading Pharma CompanyShould have experience in biosimilar injectable drug product development.To design experiments for formulation selection on the basis if the literature, patent survey. To execute the experiment and analyze the observations for optimal screening of formula. To be able to develop the lyophilized drug product (should have prior experience in lyo cycle development and scale up).Versed with QBD based drug product development. To identify the CQAs. Perform risk assessment as part of product development. Finalizing the process ranges and control strategies for the formulation and fill-finish operations.Identifying and selecting suitable container closures for the different biosimilar drug product. To plan and execute Drug product characterization studies ensuring its stability during processing, logistic and on the shelf.To manage the sterilization qualification / filter validation as part of process development. Should have good understanding on DP analytical techniques and should be able to design experiment for method development.Should have understanding on the injectable manufacturing area requirement and qualification. To manage the controlled area with supporting team and maintain the required documentation.To handle the technology transfer to different manufacturing sites work in co-ordination for smooth transfer.Designation: Research ScientistQualification M.PharmExperience 10 years to 14 years.Thanks & Regards,PriyankaExtrius Consultants & ServicesRecruitment Manager Pharma , Healthcare , Chemical & AVContact : hidden_mobileE: hidden_emailURL : www.extrius.co.in

Keyskills :
formulation developmentinjectables

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