QC Analyst II

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
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