Director, Cmc, Drug Substance

We are seeking a Director, CMC Drug Substance, to join our team. The Director, CMC Drug Substance will help manage and oversee the development and manufacturing of cGMP small molecule active pharmaceutical ingredients (APIs) for deployment in early-and late-stage clinical trials and commercial distribution. The Director, CMC Drug Substance will be a key member of a highly collaborative internal CMC team, primarily managing API development programs and manufacturing campaigns through Xenon's network of contract development and manufacturing organizations (CDMOs).

This position reports to the Senior Director, CMC Drug Substance. The level of the position will be commensurate with the candidate's education and industry experience. 

RESPONSIBILITIES:

• Manage and oversee the development and manufacturing of small molecule APIs in accordance with applicable quality and regulatory standards.
• Evaluate, recommend, and manage qualified CDMOs for the manufacture of API for clinical trials, as well as for commercial use.
• Serving as the subject matter expert, participate in audits and inspections of API CDMOs in conjunction with Quality Assurance.
• Collaborating closely with the internal process chemistry team, manage API process technology transfer to the Company's CDMOs, including process validation and the establishment and
  refinement of suitable specifications for APIs.
• Work closely with Supply Chain and CMC Drug Product colleagues to translate demand forecasts (both clinical and commercial) into API manufacturing plans.
• Author (in conjunction with Technical Writing) and/or act as a key reviewer of core CMC 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.
• Plan and manage API-related budget proposals and approved project budgets in accordance with the Company's strategic and operating plans and Finance policies.
• Direct, develop, coach and evaluate direct reports in accordance with the Company's Human Resource policies and practices.
• Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans.
• 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.
• Some international travel may be required.
• Other duties as assigned.

QUALIFICATIONS:

• PhD in Chemistry or other relevant discipline with a minimum of 10 years of directly-related experience in a pharma or biotech environment. Candidates with a MSc and significant relevant experience
  may be considered as well.
• Demonstrated track record in successfully managing development-stage and/or commercial-stage API manufacturing activities conducted 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 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, 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.