QC Analyst II

The role

This person will perform analytical and immunochemical testing to support the clinical manufacturing of biologics drug substance and drug product. They will also support method lifecycle activities, stability and release testing, clean utility monitoring, and raw material testing.

What you will do

• Performing analytical testing using UPLC, CE-SDS, icIEF, ELISA, qPCR, UV-Vis, and other methods in accordance with GMP, compendial standards, and internal SOPs
• Planning and executing release, stability, in-process, and raw material testing
• Developing, optimizing, verifying, and supporting qualification of GxP analytical methods
• Participating in method transfers, qualifications, validations, method comparisons, and stability studies
• Evaluating and reviewing analytical data for conformance to approved methods and specifications
• Troubleshooting analytical and laboratory issues and supporting investigations
• Supporting equipment and reagent selection, qualification, maintenance, and calibration
• Authoring and revising work instructions, SOPs, test methods, protocols, and reports
• Collaborating with cross-functional partners to support development, manufacture, release, and stability
• Assisting in training and mentoring junior analysts

Required qualifications

• Bachelor's degree with 5+ years of QC experience, or a Master's degree in a relevant scientific discipline with 3+ years of QC experience
• Strong knowledge of GMPs, data integrity expectations, analytical QC testing, and method qualification/validation requirements
• Hands-on experience with analytical techniques such as UPLC, CE-SDS, icIEF, qPCR, UV-Vis, and related compendial or physicochemical methods
• Hands-on experience with immunochemical methods such as ELISA
• Experience working with laboratory data systems such as LIMS and chromatography data systems
• Ability to troubleshoot analytical methods and instruments
• Detail-oriented, organized, and methodical
• Ability to work independently and as part of a team
• Clear communication in writing and in conversation
• Comfortable authoring controlled GMP documentation

Nice to have

• experience with cell-based methods is an asset
• experience with Empower is an asset

Benefits

• equity
• annual bonus dependent on individual and company performance
• 6% (non-match) RRSP contribution
• CAD $1,500 annual Active Lifestyle Allowance
• annual vacation
• professional development opportunities
• comprehensive health benefits
• Scientific and technical mentorship

Before you apply

• Please submit your application through our website and refer to Job ID 23410 in your cover letter
• We are only able to contact those who are selected for an interview

About the company

AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology.