Remote Associate Director, CMC - Drug Substance

Xenon Pharmaceuticals Inc.; Needham (MA); Hybrid; USD 170,000 - 230,000; Full time

Benefits offered by this job

Stock options

Full benefits

Tuition assistance

Job summary

Xenon Pharmaceuticals Inc. is seeking an Associate Director, CMC, Drug Substance to lead API development and manufacturing programs. You will manage CDMOs, oversee tech transfers, and ensure compliance with cGMP and regulatory requirements for clinical and pivotal trials.

The role reports to the Senior Director, CMC, Drug Substance and is based in Boston, MA with remote consideration for exceptional candidates. Travel up to 15% may be required.

Qualifications

• PhD in Chemistry or related field with extensive API/CDMO experience.
• Experience drafting/co-authoring CMC sections for IND/NDA/MAA filings.
• Deep knowledge of cGMP regulations and API regulatory requirements.
• Proven ability to manage API development and CDMO tech transfers.

Responsibilities

• Oversee development and manufacturing of small molecule APIs with CDMOs for clinical and commercial use.
• Lead API process transfer activities and establish API specifications with CDMOs.
• Coordinate API manufacturing planning based on clinical demand forecasts.
• Author/review core CMC documents and respond to regulatory authorities.
• Manage API budgets and partner with QA on audits/inspections.
• Travel up to 15% domestically and internationally.

Skills

CDMO management

CMC knowledge

Regulatory writing

Cross-functional collaboration

Communication skills

Travel readiness

Education

PhD in Chemistry

MSc in Chemistry

Job description

Xenon Pharmaceuticals Inc. is seeking an Associate Director, CMC, Drug Substance to lead API development and manufacturing programs. You will manage CDMOs, oversee tech transfers, and ensure compliance with cGMP and regulatory requirements for clinical and pivotal trials.

The role reports to the Senior Director, CMC, Drug Substance and is based in Boston, MA with remote consideration for exceptional candidates. Travel up to 15% may be required.