Director, CMC, Drug Product - Jobs in Burnaby

Job Description

Who We Are:At Xenon Pharmaceuticals (NASDAQ:XENE), we are committed to providing a brighter future for patients suffering from neurological disorders. Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver innovative medicines for patients in need. 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 pipeline of neurology-focused therapies, with a focus on commercializing novel treatments for epilepsy. Building upon the positive results and compelling data from our XEN1101 Phase 2bquot;X-TOLE quot; study in adult patients with focal epilepsy, our XEN1101 Phase 3 epilepsy program includes studies in adult patients with focal onset seizures and primary generalized tonic clonic seizures. In addition, XEN1101 is being evaluated as a treatment for major depressive disorder in both a company-sponsored Phase 2 clinical trial, as well as an investigator-led proof-of-concept study. We are also proud of the leading-edge science coming out of our discovery labs, where many innovative, early-stage research programs are underway. In addition to these proprietary programs, our pipeline includes clinical-stage partnered programs. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.About the Role:We are seeking a Director, CMC Drug Product to join our team. The Director, CMC, Drug Product will help manage and oversee the development and manufacturing of cGMP drug products (oral dosage) for deployment in mid-and late-stage clinical trials and commercial distribution. The Director, CMC, Drug Product will be a key member of a highly collaborative CMC team, managing development programs and manufacturing campaigns through Xenon #39;s network of contract development and manufacturing organizations (CDMOs).This position reports to the Senior Director, CMC Drug Product, and will be located in Boston, MA, USA.RESPONSIBILITIES:

• Manage and oversee the development and external manufacturing of clinical and commercial drug products in accordance with applicable quality and regulatory standards.
• Lead late-stage oral drug product development across the Company #39;s programs.
• Evaluate, recommend, and manage qualified CDMOs for the manufacturing of drug products for mid- to late-stage clinical trials (Phase 2/3), as well as for commercial use.
• Serve as the subject matter expert, participate in audits and inspections of drug product CDMOs in conjunction with Quality Assurance.
• Manage drug product process tech transfer to and/or between the Company #39;s CDMOs, including process validation and the establishment and refinement of suitable specifications for drug products.
• Work closely with Supply Chain Management and CMC Drug Substance colleagues to translate demand forecasts (both clinical and commercial) into drug product manufacturing plans.
• Author (in conjunction with Technical Writing) and/or act as a key reviewer of core documents/modules and other forms of submissions and responses to FDA and other Competent Authorities, providing strategic oversight and consistency for regulatory interactions, including, but not limited to, IND/NDA/MAA/IMPD filings and periodic updates thereto.
• Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans.
• Plan and manage drug product related budget proposals and approved project budgets in accordance with the Company #39;s strategic and operating plans and Finance policies.
• Direct, develop, coach and evaluate direct reports in accordance with the Company #39;s Human Resource policies and practices.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
• Ability and willingness to travel up to 25% of the time, both domestically and internationally, as some international travel may be required.
• Other duties as assigned.

QUALIFICATIONS:

• PhD in Chemistry, Pharmaceutical Sciences or other relevant discipline with a minimum of 10+ years of directly-related experience in a pharma or biotech environment.
• Demonstrated track record in successfully managing late development-stage and/or commercial-stage Drug product manufacturing activities conducted at CDMOs.
• Strong knowledge and deep understanding of solid oral dosage form development and associated modern processing technologies.
• Experience authoring/co-authoring key CMC sections in U.S. NDA and European MAA filings for small molecule drug products.
• Extensive knowledge of cGMP-related regulations, guidance documents, principles and best practices pertinent to drug products.
• Experience with CDMO selection, vendor management, contracting, issue resolution and management.
• Excellent written and oral communication skills, including the ability to communicate with scientific and non-scientific personnel and experience in applying risk-based decision-making tools.
• Excellent oral and written communication and interpersonal skills as well as the ability to build credibility and trust inside and outside the Company.
• Excellent attention to detail and commitment to providing accurate and high-quality work.
• Good organizational skills and the ability to manage multiple competing priorities.
• Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team.
• Be science and data-driven while at the same time, creative and flexible in strategic thinking and problem solving.

Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short- amp; long-term disability, accidental deathamp; dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learningamp; Development program, including a Tuition Assistance program for advanced degrees.To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.Apply Now