Abbott Pharmaceutical Scientist Job – MSc Apply Online
Scientist
Location: India – Mumbai
Category: Operations
Purpose of Role
Lead test method transfers, test method development, and validation activities primarily for biosimilar products, injectables, and vaccines. Preferable with experience in oral solids and liquid dosage forms.
Collaboration with Manufacturing, Supply Chain, Commercial, Quality Assurance, and Regulatory Affairs is critical to the success of this role.
- Troubleshoot commercial issues to avoid supply chain disruption.
- Support product localization considering cost/regulatory requirements.
- Evaluate, uphold, and provide technical expertise for compliance-related topics and activities.
- Develop expertise within the region to support an ever-expanding product portfolio and related support to the cross-functional team.
Minimum Education Qualification for the role
- Master’s degree in Pharmaceutical Science/Science/Biotechnology/Microbiology
Minimum Experience/Background for the role
- Expertise in analytical method development, validation, and troubleshooting of biosimilar products and other injectables.
- Knowledge of statistical principles and application.
- Expertise in quality compliance and pharmacopoeia standards.
- Sound knowledge of the latest trends in global regulatory benchmarks and standards.
- Strong communication skills with knowledge of technology-driven tools.
- Agile enough to adapt the strategy based on presented challenges.
- Willingness to travel and provide on-site support.
Core Responsibilities
- Support established products’ technical functions in MEAP and APAC regions 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 biosimilars and 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, and cost improvement (optimization).
- Analytical method development, validation, and troubleshooting related to established and new products within the regions (METAP-CIS/APAC).
- Provide analytical support for technology transfer of products to the region from EPD and/or I&D.
- Localization of established and new products in the METAP and APAC region.
- Provide due diligence support for business deals for new products.
- Coordinate with global product support workstreams to support the completion of global product strategies and regulatory changes/updates in the region, including GeoEx projects.
- Manage and maintain the Analytical Laboratory at the MS&T Goa site, including instrument/equipment installation, qualification, and compliance with global EQD standards.
- Prepare validation/verification/test method transfer protocols and reports, justification reports, and deficiency letter responses to the corresponding authorities. Evaluate analytical gap assessments, impact assessments, and provide appropriate strategies to overcome such gaps/impacts.
- DARIUS Coordinator for MS&T, Goa site.
Supervisory/Management Responsibilities:
- Analytical Laboratory Manager, MS&T, Goa.
- Talent development to expand the analytical expertise within the region.
