Associate Director, Analytical Development (CMC)

Xenon Pharmaceuticals Inc.; Boston (MA); Hybrid; USD 172,000 - 218,000; Full time

Benefits offered by this job

Medical benefits

Stock options

Tuition assistance

Retirement savings plan

Dental and vision benefits

Job summary

Xenon Pharmaceuticals Inc. in Boston, MA is seeking an Associate Director, CMC, Analytical Development to lead analytical method development and characterization for drug substances and products, ensuring GLP and cGMP compliance across Xenon’s internal and CRO/CDMO partners.

The role reports to the Director, CMC, Analytical Development and will be located in Boston, MA, with remote consideration for exceptional candidates. Hybrid work requires at least two onsite days per week.

Qualifications

• Ph.D. or M.S. in analytical chemistry with 10+ years of industry experience.
• Extensive analytical development, troubleshooting, and validation experience.
• Experience with GLP and cGMP compliance and regulatory filings (IND/IMPD/CTA/NDA).
• Ability to manage projects and CROs/CDMOs and coordinate with QA/Regulatory.

Responsibilities

• Design and execute phase-appropriate analytical strategies including method development and validation.
• Lead CRO/CDMO interactions and ensure GLP/cGMP compliance across studies.
• Prepare and review analytical sections of CMC regulatory submissions.
• Collaborate with QA, Regulatory, and Manufacturing to ensure GMP release of drug substances and products.
• Maintain knowledge of regulatory guidelines and industry trends.

Skills

Analytical development

Cross-functional collaboration

HPLC

Regulatory knowledge

Project management

Education

Ph.D. or M.Sc. in analytical chemistry

Tools

HPLC

GC

Dissolution

Reference standard

Job description

Xenon Pharmaceuticals Inc. in Boston, MA is seeking an Associate Director, CMC, Analytical Development to lead analytical method development and characterization for drug substances and products, ensuring GLP and cGMP compliance across Xenon’s internal and CRO/CDMO partners.

The role reports to the Director, CMC, Analytical Development and will be located in Boston, MA, with remote consideration for exceptional candidates. Hybrid work requires at least two onsite days per week.