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Principal Scientist/Senior Principal Scientist, CMC, Analytical Chemistry
2 weeks ago
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 Principal/Senior Principal Scientist, CMC, Analytical Chemistry to join our team. This position will report to the Executive Director, CMC, Analytical Development and will be responsible for the development of analytical methodology and characterization activities in support of new drug substance and new drug product development and manufacturing. He/she will provide analytical support for API and drug product manufacture in support of preclinical and clinical batches.
This position will be based out of Vancouver, BC, Canada. The level of the position will be commensurate with the candidate's education and industry experience. Relocation and immigration support will be provided, if required. This role is a hybrid position, requiring a minimum of 2 days per week in the office.
RESPONSIBILITIES:
Lead a team of scientists and research associates supporting the development of New Chemical Entities drug substance and drug product for preclinical and clinical programs within the CMC group in close collaboration with the CMC teams.
Collaborate with colleagues in Discovery to transfer product candidates into the CMC group.
Identify and recommend analytical methodologies to support chemical development, formulation development, QC, and stability testing. Lead and perform activities related to analytical method development, optimization, troubleshooting, qualification, validation, and transfer activities for starting materials, process intermediates, drug substances, drug products, internally and at CMOs.
Work with multi-functional project teams to design and execute phase-appropriate analytical strategies including analytical method development, qualification/validation, and product characterization. Represent analytical function in CMC teams and interdepartmental meetings.
Subject matter expert for impurity characterization. Track and evaluate impurity profiles for drug substance and drug product. Characterization and identify unknown impurities and their source. Develop new methods for impurity tracking.
Revolve technical issues, review deviations and investigations at contractor sites in coordination with internal and external quality control, quality assurance, and regulatory groups, as appropriate. Provide SME technical input for OOS and OOT investigations.
Author/review technical documents outlining analytical activities including method validation, reference standard and impurity characterization, stability, etc. Author/review analytical sections of chemistry, manufacturing and controls (CMC) sections of regulatory submissions.
Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external data, publications, and relevant benchmarking information to drive experimental design, data analysis, and functional/cross-functional strategy development.
Keep up to date and detailed records of experiments and data analysis within an Electronic Lab Notebook system. Ensure experiments are counter-signed on a monthly basis.
Ensure the laboratory environment is safe and well-organized; follow and keep up to date with Health & Safety policies.
Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company's Human Resource policies and practices.
Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
Some international travel may be required.
Other duties as assigned.
QUALIFICATIONS:
Ph.D. or M.Sc. in Analytical Chemistry or closely related field with a minimum of 10 years relevant industry experience directly related to analytical development for small molecule oral drug products and drug substances.
Expertise in HPLC, GC, LC-MS, and NMR.
Working knowledge of CGMPs and current industry practices.
Direct people management experience.
Excellent written and oral communication skills, including the ability to communicate with scientific and non-scientific personnel.
Self-motivated individual with excellent analytical problem-solving skills, attention to detail, and commitment to providing accurate, high-quality work.
Good organizational skills and the ability to manage multiple competing priorities.
Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team.
The base salary range for this role is $150,500 to $211,900 CAD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.
Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
As part of our hiring process, Xenon conducts background checks for finalist candidates. The types of checks conducted will vary depending on the relevance to the position.
US positions only: Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here.
To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.
