Director/Senior Director, CMC, Drug Product Manufacturing (Late Stage/Commercial)

The posting, as Xenon Pharmaceuticals wrote it

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 submitted 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 a Director/Senior Director, CMC, Drug Product Manufacturing (Late Stage/Commercial) to join our team. The Director/Senior 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/Senior Director, CMC, Drug Product Manufacturing (Late Stage/Commercial) 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
[…]
manufacturing and commercialization activities (registration, process scale up, validation and launch), including oversight of external Contract Manufacturing Organizations (CMOs).

• Experience in developing formulations of small molecule solid oral and parenteral dosage forms is a plus.
• Strong background in drug product manufacturing sciences with experience with multiple solid oral manufacturing approaches such as capsules, tablets, spray drying, granulation, blending, bottling and blistering.
• Demonstrated success in transitioning development assets to commercial products and ongoing support of commercial manufacturing.
• Experience contributing to and developing CMC sections in US and ex-US regulatory filings.
• In-depth knowledge of cGMP regulations, guidance, principles, and best practices related to drug product development and manufacture.
• Proficiency in Failure Modes Effect Analysis (FMEA) and establishment of Critical Process Parameters (CPPs).
• Experience with CDMO selection, management, contracting, and issue resolution.
• Excellent oral and written communication, leadership, and interpersonal skills, with the ability to build credibility and trust both inside and outside the company.
• Proven ability to build and develop high-performing teams, with strong delegation and conflict resolution skills.

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.