Scientist
2 months ago
Purpose of Role
Minimum Education Qualification for the role
Minimum Experience/ background for the role
Core Responsibilities
Support Established Products technical functions in MEAP and APAC region for Abbott manufacturing facilities and TPMs. Provide technical support to cross-functional teams during test method development, validation, transfer, or problem solving for a given drug product primarily of Biosimilars & Injectables. Experience in handling HPLC, UV, GC, Electrophoresis, ELISA, Peptide mapping, Bacterial Endotoxins, Bioburden, Sterility, HILIC UPLC, Real time PCR etc Provide technical support to ensure Operational activities for product continuity, product reliability, portfolio growth, cost improvement (optimize). Analytical method development, validation, and troubleshooting related to established products and new products within the regions (METAP-CIS/ APAC) Analytical support for Technology Transfer of products to the region from EPD and/or I&D. Localization of the established and new products in METAP and APAC Region. Provide Due Diligence support for business deals for new products. Co-ordinate with the global product support work streams to support completion of global product strategies and regulatory changes/updates in the region including GeoEx projects. Management and maintenance of Analytical Laboratory at MS&T Goa site, including Instrument/equipment installation, qualification, maintaining compliance according to global EQD standards. Preparation of Validation/verification/test method transfer protocols & reports, justification reports & deficiency letter response to the corresponding authorities. Evaluation of analytical gap assessments, impact assessments and providing the appropriate strategies to overcome such gaps/impacts. DARIUS Co-Ordinator for MS&T, Goa site.Supervisory/Management Responsibilities:
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