Senior Director of Analytical Development
6 days ago
Xenon Pharmaceuticals Inc. is a premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations. We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications.
Job OverviewWe are seeking a highly experienced Senior Director/Executive Director, Analytical Development to join our CMC team. The successful candidate will lead a team of analytical development scientists and external FTEs, ensuring robust analytical methodology is developed and validated to support the advancement of our portfolio of APIs and drug products.
Responsibilities- Lead the CMC Analytical Development function, accountable for developing, updating, and validating all release and stability analytical methods for drug substance and drug product.
- Closely collaborate with Quality Control and Quality Assurance to ensure timely GMP release of drug substance and drug product lots.
- Serve as a subject matter expert (SME) for analytical aspects of our regulatory filings.
- Effectively manage external contract analytical testing and method development partners.
- Develop and maintain relevant Standard Operating Procedures and other policies, procedures, and systems pertaining to the department.
- Extensive knowledge of cGMP-related regulations, guidance, principles, and best practices pertinent to the testing of both drug substances and drug products.
- Strong track record of developing, validating, and defending dissolution methods for solid oral dosage forms.
- Experience managing projects and FTEs at GMP testing CROs.
- The ability to be science- and data-driven while creative and flexible in strategic thinking and problem solving.
The base salary range for this role is CAD $193,000 - $259,100. Our Total Rewards program includes base salary, target bonus, stock options, and a full range of benefits including medical, dental, vision, short- and long-term disability, accidental death & dismemberment, life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
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