Executive Director, CMC, Drug Product

Company: Xenon Pharmaceuticals Inc.
Location: Boston
Posted on: May 23, 2025

Job Description:

Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and commercializing innovative therapeutics for neurological and psychiatric disorders. We seek talented individuals who thrive in a respectful, collaborative, inclusive, and productive culture to join our team.What We Do:Our pipeline targets high unmet medical needs, including epilepsy and depression. Our flagship program, azetukalner, is the most advanced potassium channel modulator in clinical development, with ongoing Phase 3 trials for focal seizures and plans for major depressive disorder in 2024. We also conduct early-stage research leveraging our ion channel expertise to identify new drug candidates. Supported by a strong financial position, we aim to build a leading neuroscience company with integrated discovery, development, and commercial operations.About the Role:We are seeking an Executive Director, CMC, Drug Product to oversee the development and manufacturing of cGMP drug products for clinical trials and commercial use. The role involves managing programs through CDMOs and CROs and is based in Needham, MA, with a hybrid work model requiring at least 2 days in the office.Responsibilities include:

• Leading formulation development and manufacturing of small molecule drug products from preclinical to commercialization.
• Ensuring compliance with quality and regulatory standards across development and manufacturing processes.
• Managing R&D activities related to preformulation, solid form, formulation, and technology transfer.
• Integrating preformulation and biopharmaceutics strategies to support early candidate selection.
• Developing formulation strategies for poorly soluble molecules using advanced techniques.
• Managing stability programs and packaging selections for clinical and commercial products.
• Overseeing qualified CDMOs, audits, and inspections.
• Authoring and reviewing regulatory submissions and ensuring strategic consistency.
• Staying informed on pharmaceutical development trends and guidelines.
• Aligning departmental objectives with company strategies and managing budgets.
• Leading and developing team members and ensuring compliance with company policies.
• Traveling internationally as needed and performing other duties as assigned.Qualifications:

• PhD in Chemistry, Pharmaceutical Sciences, Pharmaceutics, or related field, with 12+ years of management experience in pharma/biotech. MSc candidates with relevant experience may be considered.
• Extensive experience in drug product development and external CMO oversight.
• Expertise in solid oral and parenteral dosage forms, including pediatric formulations.
• Strong background in preformulation, solid-state characterization, and bioavailability enhancement strategies.
• Proven success in transitioning assets to commercial products and regulatory filings.
• Deep knowledge of cGMP regulations and quality practices.
• Experience with FMEA, CPPs, CMO management, and issue resolution.
• Excellent communication, leadership, and team-building skills.The salary range is $242,200 to $306,300 USD, with potential for above-range offers for exceptional candidates. Our Total Rewards include salary, bonus, stock options, comprehensive benefits, and employee development programs. We support employee well-being through various leave policies and training opportunities.Applicants will undergo background checks, and US-based candidates will participate in the E-Verify program. To apply, click "Apply Now." We appreciate all applicants; only those selected for interviews will be contacted.
  #J-18808-Ljbffr

Keywords: Xenon Pharmaceuticals Inc., Barnstable Town , Executive Director, CMC, Drug Product, Executive , Boston, Massachusetts