Company 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
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 methodsTimely review of testing records and all associated documentationConduct routine laboratory duties such as critical reagent qualifications, inventory management, and equipment maintenanceEnsure all activities adhere to regulatory (QA and EHS) and corporate requirementsOpen and progress QMS records as needed (Laboratory Investigations, Change Controls)Complete assigned training in a timely mannerMaintain laboratory data integrity by understanding applicable regulations and business processesProvide input on assay performance monitoring and trendingSupport Root Cause Analysis InvestigationsQualifications
Bachelor’s, Master’s, or Ph.D. in Biological Science with 1-3 years of QC GMP experiencePractical experience in mammalian cell culture and basic techniques (passaging, freeze-down, drug treatments) is an advantageStrong scientific and practical understanding of ELISA-based methodsProven problem-solving skills and clear communication skillsGood organizational and interpersonal skillsAbility to lead and drive projects to meet timelinesFocus on Right First Time (RFT)
Additional Information
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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