Scientist, Analytical R&D

Job Description

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief Team/department Description The role holder is responsible for the execution of Analytical method development and support activities as per Research and Development requirements (analytical activities to support product development at R&D, CRO, and CTL sites and product manufacturing at CMO/CDMO site(s)). Role Title: Scientist Analytical R&D (Experience: 4 to 6 years) Role Reports to: Analytical Tech Lead and Delivery Captain Principle Responsibilities Perform project related literature search and collect the related information. Development of all types of analytical methods required for different formulation Dosage forms. Preparation of Method development report and Standard test procedures. Conduct forced degradation studies related to identification of unknown impurities. Participate in Method validation or method transfers or verifications execution, wherever Performing the routine analytical testing for the assigned projects based on requirement Responsible for Qualification of working standards and maintenance of Standards as per storage conditions Performing routine testing for assigned projects as per requirement. Follow Good documentation practices, maintaining GLP and cleanliness in Laboratory including the safety norms. Responsible for following the data integrity requirements which are in line with regulatory expectations. Ensuring all documents and data for adequacy, accuracy, and completeness during the execution and documentation. Calibrations of instruments as applicable and review of daily calibrations whenever required. Qualifications And Education Requirements Postgraduate in Pharmacy or Science with minimum industrial experience 4 to 6 years in Analytical Research & Development department. Preferred area of expertise in Formulation Analytical R&D. Should be well versed with ICH, FDA and regulatory guidelines Should be well versed with Microsoft office applications. By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.