Senior Director/Executive Director, Analytical Development

We are seeking a Senior Director/Executive Director, Analytical Development to join our CMC team. The incumbent will be responsible for leading a team of analytical development scientists and external FTEs and for ensuring that robust analytical methodology is developed and validated (in a manner appropriate for the phase of development) to support the advancement of the Company’s portfolio of APIs and drug products.
 
This position reports to the Vice President, Product Development & Operations and will be in Vancouver, BC, Canada. We may consider remote locations for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. Relocation and immigration support will be provided, if required. 

RESPONSIBILITIES:

• Lead the CMC Analytical Development function, which is accountable for developing, updating and validating all release and stability analytical methods for drug substance and drug product.
• Ensure that analytical support is provided to the CMC Drug Substance and CMC Drug Product teams (e.g., for formulation development, in-process controls, etc.).
• Collaborate closely with Quality Control and Quality Assurance to ensure the timely GMP release of drug substance and drug product lots.
• Where required, support technology transfer efforts to or between the Company and its CDMOs (e.g., transfer and validation/co-validation of in-process control methods).
• Serve as a contributor and subject matter expert (SME) for analytical aspects of the Company’s regulatory filings (INDs, NDAs, CTAs, MAAs, PASs, etc.).
• Effectively manage the Company’s external contract analytical testing and method development partners.
• Develop and maintain relevant Standard Operating Procedures and other policies, procedures and systems pertaining to the department.
• Maintain current knowledge of issues relevant to drug development, Competent Authority regulations and guidance, as well as industry trends.
• Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans.
• Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
• Recruit, lead, direct, develop, coach and evaluate direct reports in accordance with the Company’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.
• Some international travel may be required.
• Other duties as assigned.

QUALIFICATIONS

• Ph.D. in analytical chemistry or a closely-related field with 12+ years of directly-related industry experience. Candidates with a M.Sc. and relevant experience may be considered.
• Extensive knowledge of cGMP-related regulations, guidance, principles and best practices pertinent to the testing of both drug substances and drug products in both development and commercial contexts.
• Strong track record of developing, validating and defending (in regulatory interactions) dissolution methods for solid oral dosage forms.
• Experience managing projects and FTEs at GMP testing CROs.
• Excellent oral and written communication, leadership and interpersonal skills as well as the ability to build trust and credibility inside and outside the Company.
• Proven ability to build and develop high performing teams; excellent delegation and conflict resolution skills.
• The ability to be science- and data-driven while at the same time creative and flexible in strategic thinking and problem solving.

The base salary range for this role is $193,000 to $259,100 CAD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.