QC Analyst II

AbCellera Biologics Inc.; Vancouver; On-site; CAD 76,000 - 95,000; Full time

Benefits offered by this job

Equity

Annual bonus

RRSP contribution

Job summary

AbCellera Biologics Inc. in Vancouver, BC, seeks a QC Analyst II to join the cGMPQC labs.

You will perform analytical testing for clinical manufacturing of biologics, develop and qualify methods, and support stability and release testing with cross-functional teams. You should have a Bachelor's with 5+ years QC experience or a Master’s with 3+ years, GMP knowledge, and hands-on experience with UPLC, ELISA, qPCR, icIEF, and related methods.

Qualifications

• Bachelor's degree in a scientific field with 5+ years of QC experience or a Master's with 3+ years of QC experience.
• Strong knowledge of GMPs and data integrity expectations.
• Hands-on with analytical techniques (UPLC, CE-SDS, icIEF, qPCR, UV-Vis) and immunochemical methods (ELISA).
• Experience with LIMS and chromatography data systems; Empower is a plus.

Responsibilities

• Perform analytical testing with accuracy and precision per GMP and SOPs.
• Plan and execute release, stability, in-process, and raw material testing.
• Develop and qualify GxP analytical methods for DS/DP samples.
• Participate in method transfers, validations, and stability studies.
• Review data for conformance to methods and specifications.
• Troubleshoot analytical issues and support investigations.
• Assist in training and mentoring junior analysts.

Skills

Detail-oriented

Analytical thinking

Documentation

Education

Bachelor's degree in a relevant scientific discipline

Master's degree in a relevant scientific discipline

Tools

UPLC

CE-SDS

icIEF

qPCR

UV-Vis

ELISA

LIMS

Chromatography data systems

Empower

Job description

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

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.