Associate Director, CMC Drug Substance — API Development

Xenon Pharmaceuticals; Needham (MA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Stock options

Medical, dental, vision

Short- & long-term disability

Life insurance

Travel insurance

Retirement savings with company match

Employee Assistance Program

Tuition Assistance program

Job summary

Xenon Pharmaceuticals is seeking an Associate Director, CMC, Drug Substance to join the CMC Drug Substance team in Boston, MA. The role focuses on overseeing API development and manufacturing programs with CDMOs to support clinical trials and regulatory submissions.

The position reports to the Senior Director, CMC, Drug Substance and may consider exceptional remote candidates. Travel up to 15% may be required as part of program oversight and vendor management.

Qualifications

• PhD in Chemistry or MSc with relevant pharma experience.
• Proven track record managing API development at CDMOs.
• Experience authoring CMC sections for IND/NDA/MAA filings.
• Deep knowledge of cGMP regulations related to APIs.
• Willing to travel up to 15% domestically and internationally.

Responsibilities

• Oversee development and manufacturing of small molecule APIs with CDMOs.
• Translate clinical demand into API manufacturing plans and schedules.
• Review and author core CMC documents for regulatory submissions.
• Manage API-related budgets and project financials.
• Support audits/inspections with Quality Assurance.

Skills

CDMO management

Regulatory strategy

CMC collaboration

IND/NDA submissions

Communication skills

Education

PhD in Chemistry

MSc in Chemistry

Job description

Xenon Pharmaceuticals is seeking an Associate Director, CMC, Drug Substance to join the CMC Drug Substance team in Boston, MA. The role focuses on overseeing API development and manufacturing programs with CDMOs to support clinical trials and regulatory submissions.

The position reports to the Senior Director, CMC, Drug Substance and may consider exceptional remote candidates. Travel up to 15% may be required as part of program oversight and vendor management.