Join to apply for the Executive Director, CMC, Drug Product role at Xenon Pharmaceuticals Inc.
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Join to apply for the Executive Director, CMC, Drug Product role at Xenon Pharmaceuticals Inc.
Who We Are:
Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.
What We Do: 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. Building upon positive results from our Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we plan to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our Phase 2 “X-NOVA” clinical trial. Additionally, we have pioneering science from our discovery labs, including early-stage research leveraging ion channel expertise to identify drug targets and develop new candidates. Backed by a strong balance sheet, we aim to build a fully integrated neuroscience company with robust discovery, clinical, corporate, and commercial operations.
About the Role: We seek an Executive Director, CMC, Drug Product to oversee the development and manufacturing of cGMP drug products for clinical trials and commercial distribution. The role involves managing programs and manufacturing campaigns through CDMOs and CROs, reporting to the SVP of Pharmaceutical Sciences, based in Boston, MA, with flexible consideration for other locations. This is a hybrid role requiring at least 2 days in the office weekly.
RESPONSIBILITIES:
- Lead formulation development and manufacturing of small molecule drug products from preclinical to NDA approval and commercialization.
- Ensure development and manufacturing processes comply with quality and regulatory standards.
- Manage R&D activities related to preformulation, solid forms, formulation, and drug processes, including technology transfer, process validation, and analytical methods.
- Integrate preformulation and biopharmaceutics strategies to support early candidate selection.
- Develop formulation strategies for poorly soluble small molecules using advanced techniques.
- Contribute to drug stability programs and select packaging for clinical and commercial use.
- Manage qualified CDMOs for manufacturing, scale-up, validation, and regulatory inspections.
- Author and review CMC documents for regulatory submissions and responses.
- Stay informed on pharmaceutical development trends and regulations.
- Set and align short- and long-term objectives with company strategies.
- Collaborate on global development and commercial partnerships.
- Manage budgets in accordance with company policies.
- Recruit, lead, and develop team members, ensuring compliance with HR policies.
- Adhere to company policies and conduct international travel as needed.
- Perform other duties as assigned.
QUALIFICATIONS:
- PhD in Chemistry, Pharmaceutical Sciences, Pharmaceutics, or related field with 12+ years management experience, or MSc with relevant experience.
- Extensive experience managing drug product manufacturing activities, including oversight of CMOs.
- Expertise in solid oral and parenteral dosage forms and pediatric formulations.
- Strong background in preformulation science and solid-state characterization.
- Proven success in transitioning assets to commercial products and contributing to regulatory filings.
- Deep knowledge of cGMP regulations and best practices.
- Experience with FMEA, CPPs, and managing external partnerships.
- Excellent communication, leadership, and team-building skills.
The salary range is $242,200 to $306,300 USD , with consideration for above-range for exceptional candidates. The total rewards include salary, bonus, stock options, and comprehensive benefits. Xenon values employee development and offers various programs, including tuition assistance. Background checks and E-Verify are part of our hiring process. To apply, click Apply Now. Only shortlisted candidates will be contacted.
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