Sobre este puesto de Analytical Scientist/ Scientist en Azurity Pharmaceuticals - India
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 analytical team at R&D is playing an important role in product development of various dosage forms. The analytical team involves different workflows like analytical method development, stability studies, involving method verifications at CMO/CTL and post filling activities.
This role is with Azurity R&D Analytical Scientist, which required to work in product development team’s analytical method development, Formulation sample analysis, method verification, Compendial method evaluation, Stability sample analysis and instruments calibrations.
Principle Responsibilities:
- Follow Good documentation practices
- Execution of analytical method development of Nitrosamine impurities using high end instrument and method validation parameters for developed method.
- Execution of analytical method development for unknown impurity and Genotoxic impurity identification using HPLC-PDA/UV/ELSD and LCMS techniques.
- Ensuring all documents and data for adequacy, accuracy, and completeness during the execution and documentation.
- Execution of Formulation developmental samples analysis as per ATR, recording of online documentation and completion of the analysis on time.
- Adhere to current GLP procedure, data integrity and meeting SOP compliance requirements.
- Development of Analytical methods using different analytical techniques, method verification of compendial methods, verification of Drug substance test methods.
- Follow the safety procedure in the laboratory.
- Should have exposure in preparing the STP, MDR, MOA for the allocated products.
Qualifications and Education Requirements
- Postgraduate in Pharmacy or Science.
- minimum 3 years of experience in pharmaceutical analytical R&D handling of LCMS instrument under this category.
- Well versed with analytical method development of Nitrosamine impurities in DS, DP and Excipients.
- Knowledge of unknown impurity identification using LCMS technique in DS, DP in Pharmaceutical Research and Development.
- Understating Good Laboratory Practices and Good Document Practices.
- Should have knowledge /exposure to electronic eLN/DMS systems.
- Proficient in written and spoken English.
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.