Assistant Manager - Analaytical Development(ADL)

Job Title

Assistant Manager Analytical Development (ADL) | Regulatory Markets

Job Description

We are hiring for Assistant Manager Analytical Development (ADL) for a leading pharmaceutical manufacturing company based in Mumbai.

Experience: 11-12+ Years

Location: Mumbai

Department: Analytical Development / Formulation R&D

Market: Regulatory Markets

Key Responsibilities:

• Analytical method development, optimization and validation for pharmaceutical formulations.
• Handling analytical activities for regulated markets.
• Experience in US / EU / UK / Australia markets will be preferred.
• Analytical method transfer and technology transfer from R&D to QC/manufacturing.
• Support scale-up, exhibit and registration batches.
• Stability, forced degradation and analytical troubleshooting activities.
• Preparation/review of analytical protocols, reports and technical documents.
• Coordination with R&D, QC, QA, Regulatory and manufacturing teams.
• Working knowledge of HPLC/UPLC, Dissolution, UV and other analytical instruments.
• Compliance with ICH and regulatory requirements.

Qualification: B.Pharm / M.Pharm / M.Sc. preferably Analytical Chemistry / Pharmaceutical Chemistry.