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)

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