Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
Post : Scientist
Job Description
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.
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.
Candidate Profile
• Master’s degree in Pharmaceutical Science / Science/ Biotechnology/ Microbiology
• 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.
Additional Information
Qualification : M.Pharm / M.Sc
Location : Mumbai
Industry Type : Pharma / Healthcare / Clinical research
End Date : 30th October 2024
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