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PRINCIPAL SCIENTIST III

15 - 20 years

14 - 19 Lacs

Hyderabad

Posted:1 week ago| Platform: Naukri logo

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Skills Required

method validation literature search process development data validation analytical method development r and d anda process optimization technology transfer research hplc qbd r ndds product development solid orals api doe formulation development pdr

Work Mode

Work from Office

Job Type

Full Time

Job Description

  • Lead

    formulation and process development

    of HFA-based MDI products for regulated markets (US, EU, etc.).
  • Manage

    drug-device combination product development

    , including coordination with device vendors for CMC and regulatory compliance.
  • Coordinate cross-functionally with

    analytical, regulatory, clinical, and manufacturing teams

    to ensure timely project execution.
  • Drive

    process optimization

    at the lab scale using QbD principles; establish control strategies for successful scale-up.
  • Design and define

    product specifications

    in compliance with current global regulatory guidelines.
  • Review

    Product Development Reports, Technology Transfer Reports

    , and

    Deviation/Investigation Reports

    for technical accuracy.
  • Support

    regulatory query responses

    related to product development and manufacturing in collaboration with relevant departments.
  • Lead

    technology transfer

    of HFA-based MDIs to contract manufacturing organizations (CMOs) for domestic and international markets.
  • Provide technical and regulatory support for submissions including

    NDA, ANDA, and 505(b)(2)

    applications.
  • Troubleshoot

    formulation-related issues

    during manufacturing to ensure smooth and compliant commercial production.

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    Hetero

    Pharmaceuticals

    Hyderabad

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