Principal Analytical Scientist

3 weeks ago


Mumbai, Maharashtra, India Abbott Full time

About the Role

Abbott is seeking an experienced Principal Analytical Scientist to support its technical functions in the MEAP and APAC regions. This role will be based at the Abbott manufacturing facilities and TPMs in these regions.

About You

We are looking for a highly skilled analytical professional with a strong background in supporting cross-functional teams during test method development, validation, transfer, or problem-solving for biosimilars and injectable products.

Your Key Responsibilities

  • Provide technical support to cross-functional teams during test method development, validation, transfer, or problem-solving for biosimilars and injectable products.
  • Experience in handling HPLC, UV, GC, Electrophoresis, ELISA, Peptide mapping, Bacterial Endotoxins, Bioburden, Sterility, HILIC UPLC, Real-time PCR etc.
  • 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.
  • Due Diligence support for business deals for new products.
  • Cooordinate 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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