Research Associate - Bioanalytical

Lupin; Pune District; Sur place; INR 600 000 - 800 000; Plein temps

Résumé du poste

Lupin is seeking an analytical professional to support method development and validation for inhalation and nasal products. The role requires hands-on experience with HPLC, IC and particle size instruments, ensuring data integrity and compliance with GLP, GDP and regulatory standards.

Responsibilities include routine analysis, instrument maintenance, data compilation for validation and SOP creation, contributing to regulatory submissions and quality systems within a GMP environment in Pune.

Qualifications

• Experience in method development and validation according to SOPs and regulatory guidelines.
• Ability to perform routine analysis of inhalation and nasal products.
• Capable of Invitro study sample analysis following validated bioanalytical methods.
• Proficient in operating and maintaining analytical instruments (HPLC, IC, Morphologi 4ID, Mastersizer 3000, Spraytec).
• Knowledge of GLP, GDP and data integrity requirements.

Responsabilités

• Perform method development for various molecules per SOPs and regulatory guidelines.
• Perform routine analysis of inhalation and nasal products.
• Conduct Invitro study sample analysis following validated bioanalytical methods.
• Operate and maintain analytical instruments (HPLC, ion chromatography, Morphologi 4ID, Mastersizer 3000, Spraytec).
• Carry out routine instrument calibration and performance verification.
• Compile data during method validation and sample analysis.
• Prepare SOPs related to analytical techniques and procedures.
• Adhere to GLP, GDP, data integrity and regulatory requirements.

Connaissances

Method development

Method validation

Analytical thinking

Regulatory awareness

Outils

HPLC

Ion chromatography

Morphologi 4ID

Mastersizer 3000

Spraytec

Description du poste

• Perform the Method Development and Method Validation for various molecule following the Inhouse SOPs and Regulatory guidelines.
• Perform routine analysis of inhalation and nasal products.
• Invitro Study sample analysis following the validated Bioanalytical Method.
• Operate and maintain analytical instruments such as HPLC, Ion chromatography, Morphologi 4ID, Mastersizer 3000, Spraytec/Sprayview, etc.
• Perform routine instrument calibration and performance verification
• Compilation of the data during method Validation and study sample analysis.
• Preparation of SOPs related to analytical technique and procedures.
• Follow GLP, GDP, Data Integrity and regulatory requirements.