The posting
Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown.
We're looking for an enthusiastic QC Analyst II to join our cGMP Quality Control (QC) labs and help bring our biologics programs to clinical manufacturing. In this role, you'll perform analytical and immunochemical testing that supports the clinical manufacturing of our biologics drug substance and drug product. You'll also support method lifecycle activities, stability and release testing, clean utility monitoring, raw material testing, and general laboratory readiness, working closely with the QC Team and cross-functional partners. If you're a hands-on QC professional who takes pride in accurate, timely results and wants your work to directly support clinical-stage therapies, we'd love to hear from you.
How you might spend your days
- Performing analytical testing with a high level of accuracy and precision, using techniques such as UPLC, CE-SDS, icIEF, ELISA, qPCR, UV-Vis, and other separation, immunochemical, and compendial methods, in accordance with GMP requirements, compendial standards, and internal SOPs
- Planning and executing release, stability, in-process, and raw material testing, including time-critical samples and raw material sampling, in alignment with manufacturing and program timelines
- Developing, optimizing, verifying, and supporting qualification of GxP analytical methods for drug substance (DS) and drug product (DP) samples, ensuring methods are fit for purpose and meet specifications and regulatory expectations
- Participating in method transfers, qualifications and validations, method comparisons, and stability studies, including protocol execution, data review, and report support
- Evaluating and reviewing analytical data for conformance to approved methods, specifications, and acceptance criteria, and escalating suspect or atypical results
- Troubleshooting analytical and laboratory issues, supporting investigations, identifying root cause, and implementing corrective and preventive actions
- Supporting equipment and reagent selection, qualification, maintenance, and calibration, and contributing to ongoing GMP facility readiness and laboratory process development
- Authoring and revising work instructions, SOPs, test methods, protocols, reports, and other controlled QC documentation
- Collaborating with formulation development, analytical development, process development, manufacturing, quality assurance, and regulatory affairs to support the development, manufacture, release, and stability of high-quality therapeutics
- Assisting in training and mentoring junior analysts on analytical techniques, laboratory procedures, data integrity, and GMP expectations
We’d love to hear from you if
- You have a 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
- You have strong knowledge of GMPs, data integrity expectations, analytical QC testing, and method qualification/validation requirements
- You have hands-on experience with analytical techniques such as UPLC, CE-SDS, icIEF, qPCR, UV-Vis, and related compendial or physicochemical methods, as well as immunochemical methods such as ELISA (experience with cell-based methods is an asset)
- You have experience working with laboratory data systems such as LIMS and chromatography data systems (experience with Empower is an asset)
- You troubleshoot analytical methods and instruments with confidence, evaluating atypical results and applying sound scientific judgment and root cause analysis
- You are detail-oriented, organized, and methodical, and you work well both independently and as part of a team
- You communicate clearly in writing and in conversation, and you are comfortable authoring controlled GMP documentation and working across functions
What we offer
AbCellera’s hiring range for this role is CAD $76,000 - $95,000 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, annual bonus dependent on individual 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 you’ll find a strong sense of community and connections across AbCellera through our work, clubs, and socials.
About AbCellera
Creating medicines is the most important work we can do.
We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline.
Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications.
We believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s 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 23410 in your cover letter. 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.
