CMC Analytical Development Lead – Associate Director

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

Benefits offered by this job

Base salary

Target bonus

Stock options

Medical

Dental

Vision

Disability insurance

Life insurance

Retirement plan

Employee Assistance

Job summary

Xenon Pharmaceuticals in Boston, MA is seeking an Associate Director, CMC, Analytical Development to lead analytical development for drug substances and products from preclinical to commercial manufacturing.

The role reports to the Director, CMC, Analytical Development and requires deep experience in method development, validation, and CDMO management within a GLP/gC GMP environment. Travel up to 25% is anticipated.

Qualifications

• PhD or MSc in analytical chemistry with 10+ years industry experience.
• Experience with analytical development of small molecules in various development stages.
• Extensive analytical method development, troubleshooting, and validation experience.
• In-depth development/validation of methods (HPLC, GC, dissolution) and impurity characterization.
• Knowledge of CDMO management, GMP/CMC regulatory requirements, and GLP/cGMP.
• Strong communication, leadership, and project management skills.

Responsibilities

• Design and execute phase-appropriate analytical strategies including method development and validation.
• Manage method development, qualification/validation, transfer across CROs/CDMOs.
• Identify and implement analytical methodologies for QC, stability, and formulation.
• Oversee CRO/CDMO activities and ensure GLP and cGMP compliance.
• Address technical deviations and investigations in collaboration with QA/Regulatory.
• Collaborate with QC/QA to ensure timely GMP release of drug substances/products.
• Prepare/regulatory CMC sections and participate in regulatory submissions.
• Represent analytics in CMC teams and cross-functional meetings.
• Maintain up-to-date knowledge of regulatory guidance and industry trends.
• Travel up to 25% domestically and internationally.

Skills

Analytical method development

CDMO management

cGMP compliance

GLP familiarity

Regulatory submissions

HPLC/GC methods

Team leadership

Cross-functional work

IND/IMPD experience

Education

PhD or MSc in analytical chemistry

Job description

Xenon Pharmaceuticals in Boston, MA is seeking an Associate Director, CMC, Analytical Development to lead analytical development for drug substances and products from preclinical to commercial manufacturing.

The role reports to the Director, CMC, Analytical Development and requires deep experience in method development, validation, and CDMO management within a GLP/gC GMP environment. Travel up to 25% is anticipated.