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Xenon

Senior Manager/Associate Director, CMC, Analytical Development

BostonHybrid · United States
Director+ · FullTime · R&D Operations
POSTED 22 OCTVERIFIED 1D AGO
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Role
18 days opentrue age
Posted 22 Oct
Payats field
$147k–218kposted
▼ −22% vs market median $235k
$147k$255k
Market p25–p75
$208k–$255k
Boston · n=33 · 365d to 4 Nov
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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, 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 Senior Manager/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.

Source · XenonFirst seen 7 NovOriginal ↗