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

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

resume

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