Research Associate - Analytical R&D

As an experienced professional in the field of Analytical R&D, your primary responsibilities will include the calibration of analytical instruments, preparation, and maintenance of solutions and reagents. You will be entrusted with the critical task of analyzing development batches, stability samples, and comparative dissolution profiles. Leading the analytical method development and validation processes, along with preparation of method development reports, will be a key aspect of your role. Your expertise will be crucial in conducting drug solubility studies of active pharmaceutical ingredients, as well as executing API and excipient comparability studies. You will be responsible for the daily monitoring of temperature and humidity in the stability chamber, ensuring meticulous documentation of all Analytical R&D activities. Adherence to GLP, GDP, safety protocols, and compliance guidelines within the Analytical R&D team will be essential. Collaborating effectively with cross-functional teams (CFT) to facilitate seamless product development within specified timelines will be a key part of your responsibilities. Additionally, overseeing LER-related activities and analytical method development reports for API and FDF will be within your purview. Analyzing scale-up and PO batches, managing document issuance, maintenance, and sample submission for laboratory testing will also be part of your role. To excel in this role, you are required to have an MSc degree with 2-5 years of relevant experience. Strong expertise in analytical method development and validation is essential, along with experience in comparative dissolution profile analysis and stability studies. A solid understanding of GLP, GDP, and compliance requirements will be necessary for success in this position. Your ability to collaborate effectively with CFTs for smooth development activities and maintain a detail-oriented approach to documentation, monitoring, and reporting will be critical for fulfilling the requirements of this role.,