Job Specifications
Who We Are:
Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.
What We Do:
We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In August 2025, we announced the completement of patient recruitment in our Phase 3 X-TOLE2 study and topline data are anticipated in early 2026. We also have multiple Phase 3 azetukalner clinical trials in major depressive disorder (MDD) and bipolar depression (BPD) underway, based on topline data from our Phase 2 “X-NOVA” clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates, and have recently initiated Phase 1 studies for our follow-on Kv7 channel opener, XEN1120, and our lead Nav1.7 development candidate, XEN1701, in pain. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.
About the Role:
We are seeking a full-time Quality Control Associate to join our team for an 18-month term. As a collaborative member of the Quality and CMC teams, the QC Associate will work flexibly across a number of small molecule drug programs with an emphasis on managing outsourced QC data and stability programs for the cGMP starting materials, drug substance (DS) and drug product (DP) campaigns.
This position reports to the Director, Quality Control and will be based out of Vancouver, BC, Canada. The level of the position will be commensurate with the candidate’s education and industry experience. This role is a hybrid position, requiring a minimum of 2 days per week in the office.
RESPONSIBILITIES:
Organize and coordinate the stability program activities across clinical and commercial platforms for critical starting materials, reference standards, API, and drug products.
Review, manage, and compile analytical results and reports from internal and external testing partners for product release, including investigations and resolution of deviations, OOS, and OOT observations.
Compile stability summary reports using stability management software and support trending and analysis of release and stability data through appropriate statistical tools to ensure data-driven decision making.
Coordinate stability data management activities across all programs such as storage, stability summary reports, stability protocols, and managing shelf-life extensions.
Collaborate with internal QC team, CMC Analytical, DS, DP, Regulatory Affairs, and Quality Assurance to support development and updates to specifications that meet industry standards and regulatory requirements for the appropriate phase of development.
Serve as the lead for the Specification Review Committee (SRC), collating proposed changes and managing the meeting cadence to ensure timely review and alignment across all functions.
Manage sample shipments by coordinating with internal development teams and external testing and manufacturing partners to ensure timely, compliant, and traceable transfer of materials.
Manage the reference standard inventory for clinical and commercial programs at dedicated analytical testing labs, including procurement, qualification, and distribution to all manufacturing and testing sites, while tracking the validity of all reference standard CoAs and overseeing updates based on annual requalifications.
Organize and file internal and external QC data, stability protocols, and reports for all programs.
Collaborate effectively with colleagues in Quality Control, Drug Substance, Drug Product, Analytical CMC, Regulatory Affairs, and Quality Assurance to ensure that deliverables meet the highest standards for use in clinical trials and commercial material.
Compile and assess data and emerging trends as required; support drafting, reviewing, and performing quality control checks on the drug substance and drug product sections of regulatory submissions (such as INDs, IMPDs, CTAs, NDAs) as necessary.
About the Company
Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. Our lead molecule, azetukalner, is a novel, potent, selective Kv7 potassium channel opener in Phase 3 clinical trials for the treatment of epilepsy, major depressive disorder (MDD) and bipolar depression (BPD). We are also advancing an early-stage portfolio of multiple promising potassium and sodium channel modulators, including ...
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