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.

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 of analytical raw data generated in R&D lab ensuring maintenance of data quality throughout product development and lifecycle.
• Review of standard operating procedures pertaining to analytical development, R&D and quality assurance.
• Drafting an/or review of specifications, analytical test methods, method development reports, method verification/validation protocol and reports prepared by analytical scientists working at R&D, CRO, CTL, and/or CMO/CDMO.
• Review of Drug Master File (DMF) provided by Active pharmaceutical ingredient (API) vendor and co-ordinate with them to address any deficiency.
• Evaluation of impurities from various sources, finalizing the same, and preparing their justification report.
• Preparation/Review of 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
• Troubleshooting of technical areas pertaining to analytical activities at R&D, CRO, CTL, and/or CMO/CDMO, and if required, visiting these sites for the same.
• Review of Quality management system (QMS) documents such as change controls, incidents, deviations, out of specifications (OOS) for CRO, CTL, and/or CMO/CDMO.
• Handling and responding to all analytical queries/deficiencies received from regulatory authorities.
• Monitoring of Pharmacopeia updates of API, Excipients, General chapter specific to assigned projects.
• Assessment of CRO, CTL, and/or CMO/CDMO suitability for Project requirement.
• Audit and certify contract research organization, contract testing laboratory and contract manufacturing organization, active pharmaceutical site, 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

Physical & Mental Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Must be able to sit for long periods of time
• While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
• May occasionally climb stairs and/or ride elevators
• The employee must occasionally lift and/or move up to 25 pounds
• Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
• Other miscellaneous job duties as required