Purpose of Role

• Lead test method transfers, Test method development, 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 the commercial issues to avoid the supply chain disruption.
• Support the product localization considering cost / regulatory requirement.
• Evaluate, uphold, and provide technical expertise for Compliance related topics and activities.
• Developing expertise within the region to support 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.
• Sound communication skills with knowledge of technology driven tools.
• Agile enough to adopt the strategy based on the presented challenges.
• Willingness to travel and provide on-site support.

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:

• Analytical Laboratory Manager, MS&T, Goa.
• Talent development to expand the analytical expertise within the region.