Analytical Lead at Azurity Pharmaceuticals! Chemistry & Pharma Apply Online
Analytical Lead
Hyderabad
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, gastrointestinal, 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.
Principle Responsibilities:
- Oversee all analytical activities required for supporting product development at Research and Development lab (R&D) and/or Contract Research Organization (CRO), CTL and/or CMO/CDMO.
- Provide guidance for analytical method development and method verification to analytical scientists working at R&D and CTL.
- Review analytical raw data generated in the R&D lab, ensuring maintenance of data quality throughout product development and lifecycle.
- Review standard operating procedures pertaining to analytical development, R&D, and quality assurance.
- Draft and/or review specifications, analytical test methods, method development reports, method verification/validation protocols, and reports prepared by analytical scientists working at R&D, CRO, CTL, and/or CMO/CDMO.
- Review Drug Master File (DMF) provided by Active Pharmaceutical Ingredient (API) vendors and coordinate with them to address any deficiencies.
- Evaluate impurities from various sources, finalize the same, and prepare justification reports.
- Prepare/Review various CMC study protocols and reports, e.g., IC stability study, photo-stability study, hold time study, in-use study, multi-media dissolution, dissolution development report, alcohol dose dumping, chiral purity, residual solvent justification, elemental impurities risk assessment and justification, polymorphic stability, technical summary report, etc.
- Troubleshoot technical areas pertaining to analytical activities at R&D, CRO, CTL, and/or CMO/CDMO, and visit these sites if required.
- Review Quality Management System (QMS) documents such as change controls, incidents, deviations, out of specifications (OOS) for CRO, CTL, and/or CMO/CDMO.
- Handle and respond to all analytical queries/deficiencies received from regulatory authorities.
- Monitor Pharmacopeia updates of API, excipients, and general chapters specific to assigned projects.
- Assess CRO, CTL, and/or CMO/CDMO suitability for project requirements.
- Audit and certify contract research organizations, contract testing laboratories, and contract manufacturing organizations, including active pharmaceutical sites, pertaining to Slayback projects.
- Ensure completion of required trainings and perform only those activities for which training has been completed, where required.
Qualifications and Education Requirements:
- Ph.D. in Chemistry/Pharmacy or Master’s in Chemistry or Master’s in Pharmaceuticals.
For more details and to apply for this position, visit the original notification.
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