Senior Manager, CMC Analytical Development (Hybrid)

Xenon Pharmaceuticals Inc.; United States; Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical

Dental insurance

Vision care

Short- & long-term disability

Life insurance

Employee Assistance Program

Travel insurance

Retirement savings with company match

Tuition assistance

Job summary

Xenon Pharmaceuticals Inc. in Boston, MA seeks a Senior Manager/Associate Director, CMC Analytical Development to lead analytical method development and regulatory-ready CMC documentation. Hybrid/remote options may be considered for exceptional candidates.

The role reports to the Director, CMC Analytical Development and requires 5+ (Senior Manager) or 10+ years (Associate Director) in the field, with strong GLP/cGMP knowledge and CRO/CDMO oversight.

Qualifications

• PhD or MSc in analytical chemistry; 5+ years for Senior Manager, 10+ for Associate Director.
• Extensive analytical method development, troubleshooting, and validation experience.
• Strong knowledge of GLP, cGMP, and regulatory expectations for CMC submissions.

Responsibilities

• Design and execute phase-appropriate analytical strategies including method development and validation.
• Manage method development, qualification/validation, and transfer across materials and products.
• Coordinate CROs/CDMOs and review data packages for compliance and QA readiness.
• Prepare and review analytical sections of CMC regulatory submissions (IND/IMPD/NDA/MAA).
• Collaborate with QC/QA to ensure timely GMP release of drug substance and product.

Skills

Analytical method development

CDMO management

GMP CRO management

HPLC/GC/dissolution

Regulatory filings experience (IND/IMD

Education

PhD or MSc in analytical chemistry

Job description

Xenon Pharmaceuticals Inc. in Boston, MA seeks a Senior Manager/Associate Director, CMC Analytical Development to lead analytical method development and regulatory-ready CMC documentation. Hybrid/remote options may be considered for exceptional candidates.

The role reports to the Director, CMC Analytical Development and requires 5+ (Senior Manager) or 10+ years (Associate Director) in the field, with strong GLP/cGMP knowledge and CRO/CDMO oversight.