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    Job · 18855092

    Amneal Pharmaceuticals logo

    Sr Executive, Analytical R&D Injectable

    Amneal Pharmaceuticals · Ahmedabad · onsite · Posted 30d ago

    Undisclosed5–8 yrsfulltimeSourced fromNaukri

    About a minute. You'll make an account on the way through.

    About this role

    Description:
    The position supports drug substance (DS) and drug product (DP) development through development, validation, and application of analytical methods to evaluate critical quality attributes. The role contributes to product development across dosage forms by performing quantitative, qualitative, and performance-indicative testing to align products with reference formulations. The role involves planning controlled experiments, evaluating trial batches, exposure, and stability studies, and setting product specifications. The position ensures laboratory setup, equipment compliance, and data integrity for regulatory submissions and also supports analytical method transfer, commercial troubleshooting, and exploratory computational and experimental research, leveraging scientific data to guide research decisions and innovation.

    Essential Functions:
    • Develop and apply analytical methods for DS and DP evaluation
    • Perform identification, assay, impurity, and dissolution testing
    • Evaluate formulation trials against reference product profiles
    • Plan and execute controlled experiments on trial batches
    • Conduct exposure and stability studies and document observations
    • Support setting and justification of product specifications
    • Perform analytical method validation as per intended use
    • Ensure laboratory equipment operation, maintece, and compliance
    • Maintain data integrity for regulatory submission datasets
    • Support analytical method transfer to commercial sites
    • Troubleshoot analytical issues for R&D and commercial support
    • Contribute to computational and experimental chemistry research


    Additional Responsibilities:
    • Raise indents, prepare Capex, and manage laboratory inventory.
    • Taking responsibility to give training to junior for on job training
    • Attend technical workshop /seminar and explore new technique and technology at work place
    Education:
    • Master Degree (MS/MA) M. Sc. - Required
    • M. Pharm M. Pharm - Preferred
    Experience:
    • 5 years or more in 5 - 8 Years
    Specialized Knowledge: Licenses:


    Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

    Sourced from naukri

    Skills

    TroubleshootingAnalytical Method ValidationMethod TransferAssayregulatory submissionsChemistryStability StudiesResearchmaintenancecomplianceProduct DevelopmentLaboratory EquipmentOn Job Training

    About Amneal Pharmaceuticals

    Amneal Pharmaceuticals logo

    Amneal Pharmaceuticals

    Pharma

    5.5k+

    employees

    2002

    24 years old

    Bridgewater, New Jersey

    United States (USA)

    About

    Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.

    Industries

    PharmaBiotechnologyClinical Research

    Employee ratings

    1,455 reviews

    4.2/ 5

    Culture

    4.0

    Career growth

    3.5

    Work-life

    4.2

    Employees rate it well for

    Work Culture190Senior Management93Work Life Balance87Work Environment69HR Policies65

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