Scientist, III
Summary
Performs QC testing on biopharmaceutical lots using cell-based potency assays and LISA methods, reviews documentation, maintains lab records, and ensures compliance with regulatory standards in a pharmaceutical setting.
- Support NPI QC Testing on PSBs, Clinical, PPQ, Demo and investigational lots via Cell Based Potency Assay and related [LISA methods.
- Timely review of testing records and all associated documentation.
- Routine lab duties including critical reagent qualifications, inventory
- management and equipment maintenance.
- Perform all activities are completed in line with regulatory (QA and (HS) and corporate requirements.
- Open and progress QMS records as required – Laboratory Investigations, Change Controls
- Complete assigned training on time
- Understand regulations and business processes required to maintain laboratory data integrity
- Provide input on assay performance monitoring and trending
- Supporting Root Cause Analysis Investigations
- Attend departmental and Tier meetings
- Bachelors of Science, Master’s Degree or Ph.D in a Biological
- Science,1-3 years QC GMP experience
- Practical experience of mammalian cell culture and basic techniques (Passaging, freeze-down, drug treatments) is an advantage
- Sound scientific/practical understanding of [LISA based methods.
- Proven problem solving is advantageous.
- Clear communication skills required.
- Good organizational skills and interpersonal skills required.
- Willingness to up-skill and collaborate.
- 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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