Associate Director, CMC, Analytical Development

Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE https://www.nasdaq.com/market-activity/stocks/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 https://xenon-pharma.com/pipeline to address indications with high unmet medical need, including epilepsy, depression and pain. Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. In March 2026, we announced positive topline data from our Phase 3 X-TOLE2 study of azetukalner in focal onset seizures (FOS), and we anticipate submitting a New Drug Application to the Food and Drug Administration in the third quarter of 2026. Our Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication. We also have multiple Phase 3 azetukalner clinical trials underway in major depressive disorder (MDD) and bipolar depression (BPD), based on topline data from our Phase 2 X-NOVA clinical trial. In addition, we are proud of our strong heritage in human genetics, deep understanding of ion channel biology, and expertise in novel chemistries to enable potent, selective ion channel targeting. We continue to advance an early-stage pipeline of novel therapeutic candidates, including Phase 1 studies for XEN1701 and XEN1720 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are being developed for 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 an Associate Director, CMC, Analytical Development to join our CMC team. The incumbent 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. The ideal candidate will provide guidance and support to internal and external groups to ensure products are manufactured in compliance with all applicable regulations and corporate policies and procedures (including GLP and cGMP). The candidate will provide analytical support for drug substance and drug product manufacturing in support of preclinical, clinical, registrational, validation, and commercial batches. This position reports to the Director, CMC, Analytical Development and will be located in Boston, MA, USA. We may consider remote locations for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. Hybrid positions require a minimum of two onsite days per week. RESPONSIBILITIES: - Work with cross-functional project teams to design and execute phase-appropriate analytical strategies including analytical method development and qualification/validation, establishment of specifications, reference standard qualification, and product characterization. - Manage activities related to analytical method development, optimization, troubleshooting, qualification, and validation activities for starting materials, process intermediates, drug substances, and drug products, both internally and across Xenon’s network of CDMOs. - Identify and recommend analytical methodologies to support chemical development, formulation development, QC and stability testing. - Manage analytical activities at CROs/CDMOs including method development and qualification/validation, method transfer, and characterization testing. Conduct the review of analytical raw data packages. Ensure that studies are conducted in compliance with GLP and cGMP regulations, as applicable. - Resolve technical issues, review deviation events and failure investigations at contractor sites in coordination with internal and external Quality Control, Quality Assurance, and Regulatory groups, as appropriate. Provide technical input for OOS and OOT investigations. - Collaborate closely with Quality Control and Quality Assurance to ensure the timely GMP release of drug substance and drug product lots. - Author/review technical documents outlining analytical activities including method validation, method transfer, reference standard and impurity characterization, stability. - Author/review analytical sections of chemistry, manufacturing and control (CMC) sections of regulatory submissions. - Represent the analytical function in CMC teams and interdepartmental meetings. - Maintain current knowledge of issues relevant to drug development, Competent Authority regulations and guidance, as well as industry trends. - 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. - Ability to travel up to 25% domestically and internationally. - Other duties as assigned. QUALIFICATIONS: - Ph.D. or M. Sc. in analytical chemistry or a closely-related field with 10+ years of directly-related industry experience. - Experience with analytical development of small molecules and solid oral dosage forms in various stages of development (preclinical to Phase 3). - Extensive analytical method development, troubleshooting, and validation experience. - In-depth experience with the development and validation of analytical methods (HPLC, GC, dissolution, compendial methods), the identification of impurities and degradation products, and reference standard qualification. - Demonstrated knowledge of drug development, CDMO management, manufacturing, and regulatory CMC. Extensive knowledge of cGMP-related regulations, guidance, principles and best practices pertinent to the testing of both drug substances and drug products in both development and commercial contexts. - Working knowledge of GLP and cGMP, worldwide regulatory requirements, and current industry practices. - Experience preparing and updating regulatory filings (IND, IMPD, CTA, NDA, MAA). - Ability to effectively organize and prioritize tasks to achieve established deadlines. - Ability to multi-task and adapt rapidly to changing business requirements in a dynamic corporate environment. - Proven problem-solving skills are a must. - Experience managing projects and FTEs at GMP testing CROs. - Excellent oral and written communication, leadership and interpersonal skills as well as the ability to build trust and credibility inside and outside the Company. 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.