Assistant Manager - Analaytical Development(ADL)

Navlakha Management Services; Mumbai; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Navlakha Management Services is seeking an Assistant Manager Analytical Development for a leading pharmaceutical manufacturer in Mumbai. The role focuses on analytical method development, validation, and tech transfer to QC/manufacturing, supporting regulatory submissions for US/EU/UK/Australia markets.

The candidate should have 11-12+ years of experience in Analytical Development / Formulation R&D, with strong knowledge of HPLC/UPLC, dissolution, UV, ICH guidelines and cross-functional

Qualifications

• 11–12+ years of experience in analytical development for pharmaceuticals.
• Experience with US/EU/UK/Australia regulatory markets.
• Mumbai-based, strong cross-functional collaboration.

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.

Skills

Method Development

Method Validation

Technology Transfer

Scale-up

Regulatory Affairs

Education

B.Pharm / M.Pharm / M.Sc. in Analytical/Pharmaceutical Chemistry

Tools

HPLC/UPLC

Dissolution

UV-Vis

Job description

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.