CMC Analytical Development Lead — Hybrid/Remote Options

Xenon Pharmaceuticals Inc.; New Boston (PA); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Stock options

Medical, dental, vision insurance

Disability insurance

Retirement savings with company match

Vacation and personal days

Tuition Assistance

Job summary

Xenon Pharmaceuticals Inc. in Boston, MA, USA is seeking a Senior Manager/Associate Director, CMC, Analytical Development to lead analytical method development and qualification for drug substance and drug product.

The role requires advanced degree in analytical chemistry and extensive knowledge of GLP/cGMP, CRO/CDMO oversight, and regulatory submissions. You will work with cross-functional teams to ensure compliant manufacturing and robust analytics across preclinical to commercial programs,

Qualifications

• Ph.D. or M.Sc. in analytical chemistry with 5+ years (Senior Manager) or 10+ years (Associate Director) in industry.
• Analytical development experience for small molecules and solid oral dosage forms.
• Extensive method development, troubleshooting, and validation experience.
• In-depth knowledge of analytical methods (HPLC, GC, dissolution) and impurity profiling.
• Experience with CDMO management, regulatory CMC, and GMP/GLP regulations.
• Ability to prepare regulatory filings (IND/IMPD/CTA/NDA/MAA).
• Strong leadership, organization, and communication skills.

Responsibilities

• Design and execute phase-appropriate analytical strategies including method development and validation for drug substances and products.
• Manage method development, transfer, qualification/validation, and data review across CROs/CDMOs.
• Collaborate with QA to ensure timely GMP release of drug substance and drug products.
• Prepare and review CMC sections of regulatory submissions.
• Represent analytics in cross-functional CMC teams and regulatory meetings.
• Maintain awareness of evolving regulatory guidance and industry trends.

Skills

Project management

Leadership

Cross-functional collaboration

Problem solving

Education

Ph.D. in analytical chemistry

M.S. in analytical chemistry

Tools

HPLC

GC

Dissolution

Reference standard qualification

Job description

Xenon Pharmaceuticals Inc. in Boston, MA, USA is seeking a Senior Manager/Associate Director, CMC, Analytical Development to lead analytical method development and qualification for drug substance and drug product.

The role requires advanced degree in analytical chemistry and extensive knowledge of GLP/cGMP, CRO/CDMO oversight, and regulatory submissions. You will work with cross-functional teams to ensure compliant manufacturing and robust analytics across preclinical to commercial programs,