AbbVie Westport is one of our largest pharmaceutical manufacturing sites, renowned for its commitment to innovation, quality, and excellence in supporting the development and supply of life-changing medicines. We have a opening for a Senior Scientist I to join on a 12 Month Fixed term contract. 

The Senior Scientist I, PDS&T Analytical will lead and execute the development, validation, and transfer of HPLC and ELISA analytical methods to support New Product Introductions (NPIs). The successful candidate will ensure analytical methods are scientifically sound, compliant with regulatory standards, and effectively integrated into production workflows to support both clinical and commercial supply. In addition, the role will include managing analytics for NPIs, including project management, timeline generation, coordination of release and stability testing, data trending, supporting investigations, and cross-functional team leadership.

Key Responsibilities:

• Lead development and validation of analytical methods (primarily HPLC and ELISA) for NPIs, applying quality by design (QBD) and ensuring GMP compliance.
• Oversee technology transfer of analytical methods from R&D to manufacturing, ensuring efficient integration with minimal disruption.
• Plan, execute, and track projects involving method transfer and validation, meeting all project milestones and objectives.
• Ensure all methods comply with GMP and regulatory requirements and contribute to overall quality assurance efforts.
• Collaborate with teams across R&D, quality control, manufacturing, and regulatory affairs to drive innovation and solve technical challenges.
• Proactively identify and resolve technical issues in method development and implementation.
• Prepare, review, and maintain technical documentation including protocols, reports, and SOPs.
• Train and mentor junior scientists and staff, providing guidance on method development, validation, and best practices. Support QC training during method handover.
• Integrate new technologies and approaches by staying current on industry trends and advancements.
• Communicate project status and key findings to stakeholders, ensuring transparency and alignment.