Job Title

Overview From target to the clinic. AbCelleras platform integrates biology, computation, and engineering to develop impactful antibody-based medicines. Were scientists, engineers, and business professionals who work together to turn scientific insights into breakthrough medicines. We pursue truth and scientific rigor. We think independently, act with conviction, and have the courage to work at the edge of the unknown. We offer the opportunity to stretch and explore, and to work on things that matter. Responsibilities Establishing, supporting, maintaining, monitoring, and continuously improving the QC Quality Management System (QMS) framework and associated quality system processes in compliance with applicable global CMC/GMP requirements Supporting the operation, administration, and lifecycle management of QC laboratory electronic systems (eSystems), ensuring they effectively support sample management, analysis, data acquisition, data review, and result reporting in compliance with global GMP, data integrity, and regulatory requirements Contributing to the design, implementation, and evolution of the QC data architecture, identifying eSystem capabilities needed to support QC workflows, data integrity (ALCOA++), and phase-appropriate compliance Serving as the Business Process Owner (BPO) for QC laboratory systems (e.g. LIMS, LES, CDS), overseeing system changes, enhancements, and upgrades throughout the system lifecycle Overseeing and maintaining QC eSystems master data, including user roles, permissions, system configurations, and controlled data objects Developing, reviewing, and maintaining GMP procedures, work instructions, controlled documentation, and training materials governing the compliant and effective use, administration, and data management of QC eSystems, including delivery of end-user training sessions Providing QC eSystem support for investigations, deviations, and CAPAs, including data retrieval, audit trail review, and system impact assessments Supporting qualification and computer system validation activities for QC systems (e.g., protocol and risk assessment review, validation deviations/exceptions, and lifecycle documentation) Managing QC eSystem licensing, user access, vendor relationships, and budgeting/forecasting for QC digital infrastructure Collaborating cross-functionally with QC, Quality Systems, IT, Engineering, Validation, and external vendors to ensure QC eSystems are fit-for-purpose, compliant, and aligned with laboratory and business processes What wed love to hear from you You have 5+ years of experience managing quality systems in a GxP-regulated environment, with demonstrated application of global CMC/GMP requirements and relevant regulations and guidance You have a Bachelors degree in a relevant scientific or engineering discipline with 8+ years of industry experience in biotechnology, pharmaceuticals, or life sciences You have strong understanding and hands-on experience with quality management systems and continuous improvement principles, including their application to QC laboratory operations and regulated environments You have a solid understanding of drug development processes from discovery through CMC development, with the ability to translate business and regulatory requirements into practical, compliant solutions You have experience supporting, configuring, or owning QC laboratory electronic systems (e.g., LIMS, LES, CDS) in a GMP-regulated environment, including system lifecycle management and change control You are proactive in identifying opportunities for improvement, with strong critical thinking and problem-solving skills What We Offer AbCelleras hiring range for this role is CAD $94,880 - $118,600 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution. You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And youll find we prioritize teams and social groups to build community and connections across AbCellera. About AbCellera AbCellera is a global company focused on delivering breakthrough medicines that alleviate suffering, extend lives, and improve health. Our platform includes fully integrated capabilities to create first-in-class and best-in-class antibody medicines, from discovery to clinical manufacturing. We are using our technological advantage to develop programs across multiple indications including endocrine and metabolic conditions, oncology, and inflammation and autoimmunity. Were advancing programs involving complex transmembrane proteins, bispecifics, and antibody drug conjugates. Creating medicines is the most important work we can do. When tenacious people share a vision and work together, they can truly have a positive impact. Thats why we hire for character and intelligence, not just for CVs or experience. We look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines. To apply Please submit your application through our website and refer to Job ID 23342 in your cover letter. We apologize in advance, but we receive a large volume of applications and are only able to contact those who are selected for an interview. All communication from our Talent Discovery team will come from an @abcellera.com email address. #J-18808-Ljbffr