Associate Scientist

Lupin; Pune District; On-site; INR 600,000 - 900,000; Full time

Job summary

Lupin is seeking a qualified analytical chemistry professional to lead method development, validation, and technology transfer for MDI, DPI, and Nasal products. The role emphasizes GLP, GDP, data integrity, and safety while supporting product development and lifecycle management.

The position covers routine and release testing, instrument calibration, and documentation, with opportunities to contribute to investigations, CAPA, and audits within a regulated environment.

Qualifications

• Experience in analytical method development, validation, and transfer.
• Experience with stability testing and routine analysis.
• Compliance with GLP, GDP, data integrity, and laboratory safety requirements.

Responsibilities

• Develop, optimize, and troubleshoot analytical methods for MDI, DPI, and Nasal products.
• Execute analytical method validation and technology transfer activities.
• Perform routine, release, and stability testing using analytical instruments.
• Conduct calibration, verification, and maintenance of laboratory instruments.
• Prepare and revise SOPs, protocols, specifications, and analytical reports.
• Maintain accurate laboratory documentation and ensure data integrity compliance.
• Manage laboratory consumables, reference standards, and other essential supplies.
• Ensure adherence to GLP, GDP, and laboratory safety requirements.
• Support investigations, OOS/OOT assessments, CAPA, and audit activities.

Skills

HPLC/UHPLC

GC

UV

FTIR

NGI/ACI

Sprayview

rAPSD

Particle size analysis

Education

M.Sc. / M.Pharm. in Analytical Chemistry or Pharmaceutical Sciences

Job description

Responsible for analytical method development, technology transfer, stability testing, and routine analysis of MDI, DPI, and Nasal products. Ensures compliance with GLP, GDP, data integrity, and laboratory safety requirements while supporting product development and lifecycle management activities.

Key Responsibilities:

• Develop, optimize, and troubleshoot analytical methods for MDI, DPI, and Nasal products.
• Execute analytical method validation and technology transfer activities.
• Perform routine, release, and stability testing using analytical instruments.
• Conduct calibration, verification, and maintenance of laboratory instruments.
• Prepare and revise SOPs, protocols, specifications, and analytical reports.
• Maintain accurate laboratory documentation and ensure data integrity compliance.
• Manage laboratory consumables, reference standards, and other essential supplies.
• Ensure adherence to GLP, GDP, and laboratory safety requirements.
• Support investigations, OOS/OOT assessments, CAPA, and audit activities.

Qualifications:

• M.Sc. / M.Pharm. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline.

Technical Skills:

• Hands‑on experience with HPLC/UHPLC, GC, UV, FTIR, NGI/ACI, Sprayview , rAPSD and particle size analysis.
• Knowledge of analytical characterization of inhalation and nasal products.
• Familiarity with ICH, USP, EP, and regulatory requirements.

Core Competencies:

• Analytical and problem‑solving skills.
• Technical writing and documentation.
• Attention to detail and compliance mindset.