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Job Details
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.
The Westport Bioassay Department is seeking a highly skilled Analytical Technology Specialist for a 12-month Fixed Term Contract. This role is integral to supporting the NPI group's activities in release and stability testing for products in development. The specialist will perform Cell Based Potency Assay (CBPA) and ELISA testing for both development and clinical products generated by Biologics Development Manufacturing. Additional responsibilities include new method transfers, validations, and maintaining laboratory operational excellence. Previous experience in a cGMP/GLP environment is highly advantageous.
Responsibilities
- Support NPI QC Testing on PSBs, Clinical, PPQ, Demo, and investigational lots using Cell Based Potency Assay and ELISA methods
- Timely review of testing records and all associated documentation
- Conduct routine laboratory duties such as critical reagent qualifications, inventory management, and equipment maintenance
- Ensure all activities adhere to regulatory (QA and EHS) and corporate requirements
- Open and progress QMS records as needed (Laboratory Investigations, Change Controls)
- Complete assigned training in a timely manner
- Maintain laboratory data integrity by understanding applicable regulations and business processes
- Provide input on assay performance monitoring and trending
- Support Root Cause Analysis Investigations
- Bachelor’s, Master’s, or Ph.D. in Biological Science with 1-3 years of QC GMP experience
- Practical experience in mammalian cell culture and basic techniques (passaging, freeze-down, drug treatments) is an advantage
- Strong scientific and practical understanding of ELISA-based methods
- Proven problem-solving skills and clear communication skills
- Good organizational and interpersonal skills
- Ability to lead and drive projects to meet timelines
- Focus on Right First Time (RFT)
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.
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