Description

ICompany Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

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.

Qualifications

• B.Sc. in a relevant science subject with a minimum of 10 years' experience / Or a M.Sc. with at least 8 years / Or a PhD with at least 3 years' relevant industry experience.
• Preferred experience in analytical method development, transfer, and validation.
• Proficiency with chromatographic (e.g., HPLC) and bioassay (e.g., ELISA) techniques.
• In-depth knowledge of GMP, ICH guidelines, and regulatory standards for analytical methods.
• Demonstrated project management skills and experience leading cross-functional teams.
• Strong technical problem-solving and troubleshooting abilities.
• Excellent verbal and written communication skills, able to present complex scientific data effectively.
• Proven ability to work collaboratively in a team-oriented environment.
• Understanding of the drug development process and regulatory submissions (e.g., IND, NDA).
• Experience implementing new technologies in regulated environments is desirable.
• Demonstrated leadership in coaching and mentoring staff, and leading project teams for NPIs.

Additional Information

If you are passionate about advancing pharmaceutical innovation and eager to contribute to shaping life-changing medicines at a world-class manufacturing site, we encourage you to apply for this opportunity at AbbVie Westport. AbbVie is committed to fostering a diverse and inclusive workplace where all employees are empowered to reach their full potential.

Apply today to join our team and help make a meaningful impact on patients worldwide.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.htmlI