Manager/Sr. Manager-ARD (API R&D)

10 - 15 years

14 - 15 Lacs

Posted:18 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Role Overview

must have proven experience in setting up an analytical laboratory from scratch including

Key Responsibilities

  • Lead end-to-end analytical lab setup

    (layout planning, equipment selection, installation, qualification, and system establishment).
  • Develop, optimize, and validate analytical methods for APIs and intermediates.
  • Provide analytical support for CRD & Kilo Lab scale-up,
  • Oversee in-process testing, impurity profiling, stability studies, and batch release.
  • Ensure compliance with cGMP, GLP, ICH guidelines, and data integrity standards.
  • Review and approve analytical documents: SOPs, STPs, COAs, validation protocols, and stability documents.
  • Manage analytical instruments (HPLC, GC, LC-MS, FTIR, UV, KF, DSC, TGA, etc.).
  • Train, mentor, and lead a team of analysts.
  • Implement continuous improvements and introduce new analytical technologies.

Qualifications

  • M.Sc. / M.Pharm / Ph.D. in Analytical Chemistry / Organic Chemistry or related field.
  • 1015 years of API Analytical R&D experience.
  • Mandatory:

    Experience of working in a

    start-up phase company/greenfield project

    where the analytical lab was built from zero (no setup).
  • Strong expertise in HPLC, GC, LC-MS, impurity profiling, and troubleshooting.
  • Experience in handling regulatory and customer audits.
  • Excellent leadership, communication, and documentation skills.

Preferred Skills

  • Experience with process optimization and continuous improvement techniques.
  • Experience in

    pharmaceutical development

    or

    API manufacturing

    .
  • Previous experience working with regulatory bodies (e.g., FDA, EMA).
  • Proficiency in

    process simulation tools

    (e.g., Aspen Plus, Chem CAD).

What We Offer

  • Competitive salary and benefits package.
  • Opportunity to work on cutting-edge projects in a fast-paced, dynamic environment.
  • Opportunities to work on cutting-edge R&D projects.
  • Career growth and professional development support.

How to Apply

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Applications will be reviewed on a rolling basis. We look forward to hearing from you!

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