Director, CMC, Drug Product

About the role

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, 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 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are important pain targets. 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. We are seeking a Director, CMC, Drug Product to join our team. The Director, CMC, Drug Product manages and oversees the late phase process development, validation and commercial manufacturing of cGMP drug products for deployment in late-stage clinical trials and commercial distribution. The Director, CMC, Drug Product will be a key member of a highly collaborative internal CMC team, primarily managing drug product process validation, launch and commercial manufacturing through CDMOs and CROs. This position reports to the Executive Director, CMC, Drug Product and will be based out of our Boston, MA, USA in our Needham office or in our Burnaby, BC, Canada office. We will consider other jurisdictions for exceptional candidates. This role is a hybrid position; hybrid positions require a minimum of two onsite days per week. On-site positions require up to five on-site days per week. The level of the position will be commensurate with the candidate's education and industry experience.

Responsibilities

• Lead teams in late-stage process development and scale up, process validation (PPQ) and commercial manufacturing of small molecule drug products.
• Oversee late phase development and manufacturing processes, ensuring compliance with quality and regulatory standards.
• Manage development activities related to late-stage process development and scale up, FMEA analysis, process validation (PPQ) and preparation for commercial launch of small molecules drug products at partner CDMOs and CMO.
• Manage on going commercial manufacturing and primary packaging of approved small molecule drug products by working with supply chain, quality and regulatory groups. Serve as CMC SME of commercial drug product supply.
• Manage the selection of late-stage and commercial CDMOs while considering capabilities, capacities, redundancy and quality.
• Provide input for drug product stability programs and help select appropriate packaging for clinical development and commercial use.
• Evaluate, recommend, and manage qualified CDMOs for manufacturing drug products for late-stage clinical trials, scale-up, registration, validation and commercial use. 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.
• Stay informed on pharmaceutical development and manufacturing industry science, regulatory guidelines and competitive trends to provide informed recommendations.
• Develop and propose objectives in alignment with overall company strategies and plans.
• Collaborate with development and commercial partnerships, including ex-US collaborations, to ensure global alignment and integration of strategies.
• Plan and manage budget proposals and ap

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