Research Associate - Analytical R&D

2 - 6 years

0 Lacs

Posted:1 day ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As an Analytical R&D Scientist, you will be responsible for various tasks including calibration of analytical instruments, preparation and maintenance of solutions and reagents. You will analyze development batches, stability samples, and dissolution profiles. Your role will involve leading method development, validation, and preparing reports. Additionally, you will conduct drug solubility studies and comparability studies of active pharmaceutical ingredients and excipients. It will be your duty to monitor stability chamber conditions, maintain proper documentation, and adhere to GLP, GDP, safety protocols, and compliance guidelines. Key Responsibilities: - Responsible for calibration of analytical instruments and preparation/maintenance of solutions and reagents. - Conduct analysis of development batches, stability samples, and dissolution profiles. - Lead analytical method development, validation, and report preparation. - Perform drug solubility studies and execute API & excipient comparability studies. - Monitor stability chamber conditions and ensure proper documentation. - Follow GLP, GDP, safety protocols, and compliance guidelines. - Coordinate with cross-functional teams for product development. - Execute LER-related activities and oversee analytical method development reports. - Analyze scale-up and PO batches while managing document issuance and sample submission. Qualifications Required: - MSc degree with 2-5 years of experience. - Strong expertise in analytical method development and validation. - Experience in comparative dissolution profile analysis and stability studies. - Understanding of GLP, GDP, and compliance requirements. - Ability to collaborate effectively with cross-functional teams. - Detail-oriented approach to documentation, monitoring, and reporting.,

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