Job Overview
Location
Boston
Job Type
Full-time
Category
Other Engineering
Date Posted
May 3, 2026
Full Job Description
đź“‹ Description
- • The Director/Senior Director, CMC, Drug Substance will lead the development and manufacturing of cGMP small molecule active pharmaceutical ingredients (APIs) for late-stage clinical trials through commercial validation, playing a critical role in advancing Xenon’s neuroscience pipeline, including the Phase 3 azetukalner program for epilepsy and depression.
- • Day-to-day responsibilities include managing CDMO selection and technical transfer, overseeing API process development and validation, authoring or reviewing CMC sections for regulatory submissions (IND/NDA/MAA), collaborating with process chemistry, supply chain, and drug product teams, managing API-related budgets, and leading direct reports through recruitment, coaching, and performance evaluation.
- • Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company with a strong pipeline targeting high unmet medical needs in epilepsy, depression, and pain, backed by a robust balance sheet and a culture of respect, collaboration, inclusion, and productivity, headquartered in Boston with hybrid work flexibility.
- • In this role, the individual will deepen expertise in global regulatory strategy for API submissions, strengthen leadership in cross-functional CMC teams, gain end-to-end ownership of API lifecycle management from development to commercialization, and contribute directly to the approval and launch of novel neuroscience therapeutics.
🎯 Requirements
- • PhD in Chemistry, Chemical Engineering or other relevant discipline with a minimum of 10 years of directly-related experience in a pharma or biotech environment (MSc with significant experience may be considered)
- • Demonstrated track record in managing development-stage and/or commercial-stage API manufacturing activities at CDMOs
- • Experience authoring/co-authoring key CMC sections in U.S. NDA and European MAA filings for small molecule APIs
- • Extensive knowledge of cGMP-related regulations, guidance documents, principles, and best practices pertinent to APIs
- • Experience with CDMO selection, vendor management, contracting, issue resolution, and management
- • Excellent written and oral communication skills, including ability to communicate with scientific and non-scientific personnel and apply risk-based decision-making tools
🏖️ Benefits
- • Base salary, target bonus, and stock options
- • Full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, life insurance, Employee Assistance Program, travel insurance, and retirement savings with company matching
- • Vacation, personal days, sick days, and an end-of-year company shutdown
- • Expanding Training, Learning & Development program including Tuition Assistance for advanced degrees
Skills & Technologies
About Xenon
Xenon is a leading provider of advanced data analytics and artificial intelligence solutions. The company specializes in developing and implementing cutting-edge technologies that help businesses unlock the full potential of their data. Xenon's offerings include predictive modeling, machine learning algorithms, and data visualization tools, all designed to drive informed decision-making and operational efficiency. They serve a diverse range of industries, including finance, healthcare, and retail, empowering clients to gain deeper insights, optimize performance, and achieve strategic business objectives. Xenon is committed to innovation and delivering tangible value through data-driven strategies.
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