Senior Director, Quality Control – DS/DP (Hybrid)

Xenon Pharmaceuticals Inc.; Boston (MA); Hybrid; USD 172,000 - 218,000; Full time

Benefits offered by this job

Stock options

Medical insurance

Tuition assistance

Vacation days

Job summary

Xenon Pharmaceuticals Inc., a neuroscience-focused biopharmaceutical company, seeks an Associate Director to lead Quality Control activities supporting clinical and commercial drug substance (DS) and drug product (DP) programs in accordance with ICH and cGMP requirements.

The ideal candidate will have strong background in small molecules, spanning early to late clinical phases through registration, PPQ, and commercial stages.

Qualifications

• Undergraduate degree in life sciences with 8+ years of management experience in the pharmaceutical industry (small molecules and/or biologics).
• Experience auditing external laboratories; FDA/EMA inspections; inspection readiness is preferred.
• Strong experience with quality control testing, stability program management in accordance with ICH guidelines, master specifications, method validations, investigations (OOS/OOT).

Responsibilities

• Manage master specifications for starting materials, reference standards, API, and drug products for assigned clinical/commercial program(s).
• Lead the assigned program’s stability activities, including trending and statistical evaluation of stability data.
• Manage stability studies for reference standards, API, and drug products for assigned programs and monitor data.
• Lead investigations and draft reports for OOS and OOT results during release and stability testing.
• Review, manage analytical/non-analytical results for product release and stability, including OOS/OOT observations.
• Engage with external labs and CMOs, perform remote/on-site audits as required.
• Oversee transfer of drug candidates from discovery to CMC teams and coordinate with QA for release documents.

Skills

Quality Control

Stability Testing

ICH & cGMP

Analytical Testing

Team Leadership

Education

Bachelor's degree in life sciences

Job description

Xenon Pharmaceuticals Inc., a neuroscience-focused biopharmaceutical company, seeks an Associate Director to lead Quality Control activities supporting clinical and commercial drug substance (DS) and drug product (DP) programs in accordance with ICH and cGMP requirements.

The ideal candidate will have strong background in small molecules, spanning early to late clinical phases through registration, PPQ, and commercial stages.