--- title: 'Associate Director, CMC, Drug Product at Xenon Pharmaceuticals' canonical: 'https://feeny.ai/job/associate-director-cmc-drug-product-xenon-pharmaceuticals-vancouver-fqxm9mxz10yv' type: 'job' last_seen: '2026-09-03' --- # Associate Director, CMC, Drug Product at Xenon Pharmaceuticals - **Company:** Xenon Pharmaceuticals - **Location:** Vancouver, Canada - **Employment:** full-time - **Work type:** hybrid - **Posted:** 2026-09-01 - **Last confirmed live:** 2026-09-03 - **Apply:** https://jobs.ashbyhq.com/xenon/3b46d562-c58f-486f-b45b-0a7a2678c4ed ## Job description 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, Drug Product, to join our team. The Associate Director, CMC, Drug Product will manage and oversee the early-stage assessment and formulation development of drug products pre-clinical and early stage Phase 1 and 2 clinical programs. The candidate will be a key member of highly collaborative internal Drug Product and CMC teams, primarily managing discovery and toxicology formulation, developability evaluation of candidate molecules, and Phase 1 and 2 formulation and manufacturing process development. This position reports to the Director, CMC, Drug Product and will be based out of Vancouver, BC, Canada in our Burnaby office. We may consider other jurisdictions for exceptional candidates. This role is a hybrid position, requiring a minimum of 2 days per week in the office. ## RESPONSIBILITIES: - Lead non-clinical formulation and early phase clinical formulation and process development activities of small molecule drug products. Effectively communicate with cross-functional teams to ensure CMC decisions support current and upcoming phases of drug development. - Manage activities related to early-stage formulation development including drug substance attribute profiling, developability assessments and executing plans for first in human phase 1 and phase 2 formulation development. Provide updates to product development teams and program manager as required. - Manage and coordinate clinical trial material manufacturing and packaging for early-stage small molecule assets with assigned Clinical Supply colleagues. - Manage the selection of early-stage CDMOs while considering capabilities, capacities, redundancy and quality. Partner with QA GMP colleagues as required. - Provide input for drug product stability programs and help select appropriate packaging for clinical development in collaboration with Analytical colleagues. - Evaluate, recommend, and manage qualified CROs and CDMOs for manufacturing drug products for discovery, non-clinical and toxicology formulations as well as for early phase clinical trials. Collaborate with Quality Assurance to manage audits and inspections of CDMOs and on manufacturing investigations. - Author and review core CMC documents/modules and other submissions and responses to FDA and other Competent Authorities, ensuring strategic oversight and consistency for regulatory interactions, including IND/NDA/MAA/IMPD filings and periodic updates. - Write, review and/or approve relevant documentation required to support drug development including batch records, specifications, development reports, development protocols and other necessary documentation. - Stay informed on discovery and non-clinical formulation development, pharmaceutical development and manufacturing industry science, regulatory guidelines and competitive trends to provide informed recommendations. - Collaborate with discovery, early and late development partnerships, including ex-US collaborations, to ensure global alignment and integration of strategies. - 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: - PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Pharmaceutics, or a related discipline with at least 10+ years of relevant experience in a pharma or biotech environment. Candidates with a BSc or MSc and relevant experience will also be considered. - Experience in managing early-stage drug product development and manufacturing activities (first in human and proof of concept formulations), including oversight of external Contract Manufacturing Organizations (CMOs). - Strong background in powder based small molecule drug product development with experience on capsules, tablets, spray drying, granulation, blending, bottling and blistering. - Experience developing solutions, suspensions, granules or powders for suspension, chewable tablets, buccal/sublingual tablets is a plus. - Experience with PK exposure modeling and drug developability is a plus. - Experience supporting discovery, non-clinical and toxicology formulation development including parenterals, solutions, suspensions, lipids/SEDDS/SMEDDS, amorphous or salt forms. Experience in developing formulations of small molecule parenteral dosage forms is a plus. - Experience developing and progressing enabled formulations such as spray dried dispersions, hot melt extrusion, lipid softgels, nano-formulations to the clinic is a plus. - Experience contributing and developing CMC sections for regulatory filings (i.e. US and ex-US) is required. - In-depth knowledge of cGMP regulations, guidance, principles, and best practices related to drug product development and manufacture is required. - Experience with CDMO selection, management, contracting, and issue resolution. Experience working with global CDMOs is required. - Excellent oral and written communication, leadership, and interpersonal skills, with the ability to build credibility and trust both 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. ## About Xenon Pharmaceuticals ## Company Overview - **One-liner**: Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing therapeutics for people living with neurological and psychiatric disorders. - **Entity Type**: Public (Ticker: XENE on Nasdaq) - **Headquarters**: Burnaby, British Columbia, Canada - **Founded**: 1996 - **Founders**: Not publicly listed as individual founders; the company was founded based on a platform science capable of discovering new genetic targets to treat human disease. ## Core Business - **Primary industry/industries**: Biotechnology, Neuroscience, Pharmaceuticals - **Target customers**: Patients with neurological and psychiatric disorders (epilepsy, major depressive disorder, bipolar depression, pain); healthcare providers; payers. - **Mission or purpose statement**: "To deliver innovative medicines that provide a brighter future for people living with neurological and psychiatric disorders." [xenon-pharma.com](https://xenon-pharma.com/about) ## Products & Services Xenon’s pipeline is focused on ion channel science, specifically potassium (KV7) and sodium (NaV) channel modulators. - **Azetukalner (KV7 Potassium Channel Opener)**: The lead late-stage investigational candidate. It is in multiple Phase 3 clinical trials for: - Focal onset seizures (Phase 3 X-TOLE2 completed, X-TOLE3 ongoing) - Primary generalized tonic-clonic seizures (Phase 3 X-ACKT) - Major depressive disorder (Phase 3 X-NOVA2 and X-NOVA3) - Bipolar depression (Phase 3 X-CEED) - **XEN1120 (KV7 Potassium Channel Opener)**: An early-stage (Phase 1) candidate for the treatment of pain. - **XEN1701 (NaV1.7 Sodium Channel Inhibitor)**: An early-stage (Phase 1) candidate for the treatment of pain. - **NBI-921355 (Partnered with Neurocrine Biosciences)**: A NaV1.2/1.6 inhibitor in development for epilepsy, pain, and psychiatry. [xenon-pharma.com](https://xenon-pharma.com/pipeline) ## Market Standing - **Valuation/Market Cap**: Not publicly available in the provided search results. As a public company, this fluctuates daily. - **Key Metric**: Annual Revenue of $7.5M (as per LinkedIn). As a clinical-stage biotech, the primary focus is on pipeline progress and cash runway rather than revenue. - **Notable Investors/Partners**: Neurocrine Biosciences (partner for NBI-921355). The company has also had strategic partnerships with multiple premier biopharmaceutical companies focused on pain, metabolic, and cardiovascular disease. [xenon-pharma.com](https://xenon-pharma.com/about) - **Growth Signals**: The company is in a significant growth phase, having initiated multiple Phase 3 clinical trials for its lead candidate, azetukalner, across epilepsy, major depressive disorder, and bipolar depression. This represents a major expansion of its clinical pipeline and a transition towards a late-stage, fully integrated biopharmaceutical company. [xenon-pharma.com](https://xenon-pharma.com/about) ## Competitive Advantages - **Deep Expertise in Ion Channel Biology**: Xenon is one of the scientific leaders in ion channel drug discovery, with a specific focus on potassium (KV7) and sodium (NaV) channel modulators. This is a highly specialized and technically difficult area of drug development. [xenon-pharma.com](https://xenon-pharma.com/about) - **Proprietary Pipeline**: The company has a wholly-owned, late-stage pipeline led by azetukalner, a novel KV7 potassium channel opener being studied across multiple high-need indications (epilepsy, MDD, bipolar depression). This provides significant potential upside and control over its future. - **Strong Scientific Foundation**: Founded on a platform capable of discovering new genetic targets, the company has a deep history of translating genetic insights into novel therapeutic candidates. [xenon-pharma.com](https://xenon-pharma.com/about) - **Strategic Partnerships**: A history of partnerships with premier biopharmaceutical companies (e.g., Neurocrine Biosciences) validates its platform and provides non-dilutive funding. [xenon-pharma.com](https://xenon-pharma.com/about) ## Strategic Focus - **Advancing Late-Stage Pipeline**: The primary focus is on executing the Phase 3 clinical programs for azetukalner across epilepsy, major depressive disorder, and bipolar depression, with the goal of regulatory approval and commercialization. - **Expanding Early-Stage Pipeline**: Continuing to advance early-stage candidates (XEN1120, XEN1701) for pain and other high-need indications. - **Building a Fully Integrated Company**: Transitioning from a discovery and development company to one with commercial capabilities, as evidenced by the hiring of a Chief Commercial Officer. [xenon-pharma.com](https://xenon-pharma.com/about) - **Deepening Ion Channel Leadership**: Maintaining its position as a scientific leader in ion channel drug discovery, with a deep focus on potassium (KV7) and sodium (NaV) channel modulators. [xenon-pharma.com](https://xenon-pharma.com/about) ## Why Work Here - **Mission-Driven Work**: Employees are united by a clear and compelling mission to deliver innovative medicines for patients with neurological and psychiatric disorders who have been underserved for too long. [xenon-pharma.com](https://xenon-pharma.com/about) - **Culture of Collaboration and Impact**: The company describes itself as collaborative, ambitious, resilient, ethical, and science-driven. The culture is shaped by the "XenonCARES" program, which focuses on professional growth, wellness, and community. [xenon-pharma.com](https://xenon-pharma.com/join-us) - **Competitive Compensation & Benefits**: Offers a total compensation package including base salary, performance-based bonuses, and equity. Benefits include comprehensive medical, dental, and vision coverage (US and Canada), a retirement savings program with a generous employer match, and a tuition reimbursement program. [xenon-pharma.com](https://xenon-pharma.com/join-us) - **Work Flexibility**: The company values flexibility and provides a stipend for work-from-home setups. They also offer generous paid vacation time and an annual holiday shutdown. [xenon-pharma.com](https://xenon-pharma.com/join-us) - **Growth & Development**: Recognizes and supports team member growth through leadership and development opportunities, a tuition reimbursement program, and recognition programs for both big and small wins. [xenon-pharma.com](https://xenon-pharma.com/join-us) - **Work Model**: Hybrid/Remote-friendly with a stipend for home office setups. Offices are located in Burnaby, British Columbia (HQ) and the United States. [xenon-pharma.com](https://xenon-pharma.com/join-us) - **Diversity & Inclusion**: The company states it cultivates and celebrates diversity, viewing diverse backgrounds, experiences, and opinions as a great asset, and is committed to fostering a safe and inclusive environment. [xenon-pharma.com](https://xenon-pharma.com/join-us) ## Sources 1. [xenon-pharma.com](https://xenon-pharma.com/) 2. [xenon-pharma.com](https://xenon-pharma.com/about) 3. [xenon-pharma.com](https://xenon-pharma.com/join-us) 4. [xenon-pharma.com](https://xenon-pharma.com/pipeline) 5. 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