Associate Director, CMC Drug Product (Hybrid, Boston)

Xenon Pharmaceuticals Inc.; Needham (MA); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical, dental, vision

Stock options

Retirement savings plan

Paid time off

Job summary

Xenon Pharmaceuticals Inc. in Needham/Boston region is seeking an Associate Director, CMC, Drug Product to lead early-stage formulation development and manage CMC activities across discovery and Phase 1/2 programs.

The role requires a PhD with 10+ years of pharma experience, expertise in small-molecule drug product development, CDMO management, and regulatory submissions, with a hybrid work setup and occasional travel.

Qualifications

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

Responsibilities

• Lead non-clinical formulation and early phase clinical formulation and process development for small molecule drugs.
• Manage early-stage formulation development including developability assessments and first-in-human plans.
• Coordinate clinical trial material manufacturing and packaging for early-stage assets.
• Select and manage CDMOs and QA/ GMP collaborations.

Skills

Leadership

CMC expertise

Regulatory submissions

Project management

Cross-functional collaboration

Education

PhD in Chemistry or related

Job description

Xenon Pharmaceuticals Inc. in Needham/Boston region is seeking an Associate Director, CMC, Drug Product to lead early-stage formulation development and manage CMC activities across discovery and Phase 1/2 programs.

The role requires a PhD with 10+ years of pharma experience, expertise in small-molecule drug product development, CDMO management, and regulatory submissions, with a hybrid work setup and occasional travel.