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Analytical Lead

Analytical Lead

ConfidentialHyderabad / Secunderabad, Telangana, India
4 days ago
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.

Role Description

  • This role holder is responsible for completing cycle project deliverables specific to Analytical activities to support the product development team at R&D to commercial team.
  • Coordination with CRO, CTL, CMO / CDMO site(s) for smooth execution of analytical activities.

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 standard operating procedures pertaining to analytical development, R&D and quality assurance.
  • Drafting and / 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.
  • Review of analytical raw data generated in R&D lab ensuring maintenance of data quality throughout product development and lifecycle.
  • 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., ICH stability study, photostability 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.
  • Specific Skills Required

  • Minimum Doctorate / Postgraduate in Pharmacy or Science.
  • Minimum 16 years' experience in pharmaceutical R&D or equivalent.
  • Interpretation of analytical data with respect to different analytical techniques / formulation matrix Peo le management, communication skills and troubleshooting skills of analytical issues.
  • 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.

    Skills Required

    Analytical method development, CMC study protocols, Analytical test methods, Specifications, Standard operating procedures, Validation protocol, Method verification

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