Associate Director, CMC Analytics (Analytical Dev)

Xenon Pharmaceuticals; Boston; Hybrid; PHP 11,285,000 - 15,047,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Disability coverage

Life insurance

Retirement plan with company match

Tuition assistance

Job summary

Xenon Pharmaceuticals in Boston, MA seeks an Associate Director, CMC, Analytical Development to lead analytical method development and qualification activities across drug substances and products. The incumbent will guide internal and external groups to ensure GLP and cGMP compliance throughout preclinical to commercial stages.

The role involves directing CRO/CDMO collaborations, authoring regulatory submissions, and maintaining knowledge of regulatory expectations and industry trends.

Qualifications

• Ph.D. or M.Sc. in analytical chemistry with 10+ years of industry experience.
• Experience developing analytical methods for small molecules and solid oral dosage forms.
• Extensive method development, troubleshooting, and validation experience.
• Knowledge of cGMP and GLP; experience with regulatory filings (IND/IMPD/NDA).

Responsibilities

• Design phase-appropriate analytical strategies and method qualification/validation.
• Collaborate with CROs/CDMOs for method development and transfer.
• Support regulatory submissions with analytical sections of CMC.
• Ensure timely GMP release of drug substance and drug product lots.
• Travel up to 25% domestically and internationally.

Skills

Analytical method development

HPLC

GC

Dissolution testing

Regulatory submissions

CDMO management

GLP/cGMP knowledge

Education

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

Tools

HPLC

GC

Dissolution testing

Reference standard qualification

Job description

Xenon Pharmaceuticals in Boston, MA seeks an Associate Director, CMC, Analytical Development to lead analytical method development and qualification activities across drug substances and products. The incumbent will guide internal and external groups to ensure GLP and cGMP compliance throughout preclinical to commercial stages.

The role involves directing CRO/CDMO collaborations, authoring regulatory submissions, and maintaining knowledge of regulatory expectations and industry trends.