Associate Director, CMC Drug Product – Early-Phase Dev

Xenon Pharmaceuticals Inc.; Burnaby; Hybrid; CAD 150,000 - 190,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Disability insurance

Tuition assistance

Retirement savings

Job summary

Xenon Pharmaceuticals Inc. in Vancouver, BC, Canada, invites applications for an Associate Director, CMC, Drug Product to lead early-stage formulation development and manage external CDMOs, ensuring regulatory alignment for IND/NDAs.

The role collaborates across Drug Product and CMC teams, oversees development from discovery to early clinical stages, and requires a PhD with 10+ years in pharma/biotech. Hybrid work with 2 days in the Burnaby office.

Qualifications

• PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Pharmaceutics, or related field with 10+ years in pharma/biotech.
• Experience in leading early-stage drug product development and CMOs oversight.
• Strong background in small molecule drug product development and formulations.

Responsibilities

• Lead non-clinical and early phase formulation and process development activities for small molecule drug products.
• Coordinate CDMO selection and management for manufacturing of drug products.
• Prepare and review CMC sections and submissions for IND/ NDA/MAA filings.
• Collaborate with discovery and development teams to align global strategies.
• Ensure regulatory compliance and quality oversight across development programs.

Skills

Leadership

Regulatory affairs

CMC development

Drug product

Project management

Cross-functional teams

Strategic planning

Education

PhD in Chemistry or related field

Tools

CDMO management

Job description

Xenon Pharmaceuticals Inc. in Vancouver, BC, Canada, invites applications for an Associate Director, CMC, Drug Product to lead early-stage formulation development and manage external CDMOs, ensuring regulatory alignment for IND/NDAs.

The role collaborates across Drug Product and CMC teams, oversees development from discovery to early clinical stages, and requires a PhD with 10+ years in pharma/biotech. Hybrid work with 2 days in the Burnaby office.