Analytical Development Laboratory (ADL)

BookMyMentor; Ahmedabad District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

BookMyMentor is seeking a Senior Analytical Development Laboratory professional with over 5 years of experience, focused on injectable/formulation activities in Ahmedabad, India.

The role involves planning analytical activities, maintaining GLP compliance, and providing training on documentation practices. This position offers an opportunity to contribute to regulatory submissions and analytical activities.

Qualifications

• 5+ years of experience in analytical development.
• Hands-on exposure to analytical method development and validation.
• Good team coordination and effective documentation practices.

Responsibilities

• Plan analytical activities for assigned projects.
• Review routine and stability sample analysis.
• Maintain GLP compliance in laboratory operations.
• Provide training on GLP and documentation practices.
• Support for regulatory dossier submissions.

Skills

Experience in Injectable/Formulation analytical activities

Strong understanding of GLP

Documentation practices

Team coordination

Planning skills

Job description

Analytical Development Laboratory (ADL)

Senior Level (5+ years)

Responsibilities

• Planning of analytical activities for assigned projects
• Review of routine (F&D) and stability sample analysis along with compilation
• Review of specifications and standard test procedures for raw materials and finished products
• Review of analytical method development, partial validation, and API verification activities
• Maintaining GLP compliance in laboratory operations as per regulatory requirements
• Providing training to subordinates on GLP and good documentation practices
• Proper archival and maintenance of analytical reports and laboratory documents
• Effective utilization of laboratory equipment and manpower
• Coordination and support to F&D, QA, QC, and RA for analytical‑related activities
• Support for regulatory dossier submissions and query responses
• Planning analyst qualification activities for new scientists
• Analytical budget planning for newly assigned projects

Requirements

• Experience in Injectable/Formulation analytical activities
• Strong understanding of GLP, documentation practices, and regulatory expectations
• Hands‑on exposure to method development and validation activities
• Good team coordination and planning skills