Executive/Research Associate/Scientist

Analytical Method Development Scientist (Injectable, Derma, and OSD Formulations)

Experience: 4 7 years

JOB RESPONSIBILITY

Job Summary:

The role involves developing and validating robust analytical methods, with a primary focus on Assay, RS, GC, PSD, and Dissolution for Injectable, Derma, and OSD formulations. The candidate will be responsible for literature search, method optimization, troubleshooting, and ensuring smooth execution of projects. Collaboration with cross-functional teams, guiding peers, and maintaining compliance with regulatory standards are key aspects of this role.

Key Responsibilities:

• Conduct literature searches for formulation analytical methods to support method development.
• Develop, optimize, and validate methods for Assay, RS, GC, PSD, and Dissolution, ensuring regulatory compliance.
• Troubleshoot and resolve analytical method issues and provide technical guidance for complex analytical challenges.
• Ensure timely completion of method development and validation activities.
• Collaborate with cross-functional teams (QC, QA, RA, Formulation Development) for seamless project execution.
• Ensure smooth execution for all the developmental projects
• Review and approve FAD documents, including Lab Notebooks, Lab Records, STPs, Specifications, AMV protocols/reports, Method Transfer documents, and Change Control documents.
• Ensure compliance with regulatory guidelines (ICH, USP, EP, FDA) and maintain high documentation standards.
• Review qualification and calibration documents of analytical equipment/instruments.
• Conduct knowledge-sharing sessions to enhance team competencies.
• Address queries from internal and external customers and regulatory agencies.
• Identify advancements in analytical technologies and recommend strategic improvements.
• Participate in continuous improvement initiatives to enhance productivity and efficiency in method development.
• Review of Standard operating procedures in the Analytical Research and Development (Formulation Analytical Development) and Formulation development.
• Review of documents from the API Manufacturers, Technology transfer documents and documents from the Contract testing laboratories and Contract manufacturing facilities.
• Performing assigned tasks by HOD/Designee as and when required as per Organization requirements.