About this role
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 Investigations 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) 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.html