What are the responsibilities and job description for the Associate Director/Director, CMC, Analytical Development position at Xenon Pharmaceuticals Inc.?
Associate Director / Director, CMC, Analytical Development
Boston, MA, USA Req #336
Friday, February 14, 2025
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 the positive results and compelling data 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 are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our Phase 2 “X-NOVA” clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. 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 an Associate Director / Director, CMC, Analytical Development to join our CMC team. The incumbent will be responsible for the development of analytical methodology and characterization activities in support of new drug substance and new drug product development and manufacturing. He / she will provide guidance and support to internal and external groups to ensure that products are manufactured in compliance with all applicable regulations and corporate policies and procedures (including GLP and cGMP). He / she will provide analytical support for drug substance and drug product manufacturing in support of preclinical, clinical, registrational, validation, and commercial batches.
This position reports to the Executive Director, CMC, Analytical Development and will be located in Vancouver, BC, Canada or Boston, MA, USA. 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 :
- Work with cross-functional project teams to design and execute phase-appropriate analytical strategies including analytical method development and qualification / validation, establishment of specifications, reference standard qualification, and product characterization.
- Manage activities related to analytical method development, optimization, troubleshooting, qualification, and validation activities for starting materials, process intermediates, drug substances, and drug products, both internally and across Xenon’s network of CDMOs.
- Identify and recommend analytical methodologies to support chemical development, formulation development, QC and stability testing.
- Manage analytical activities at CROs / CDMOs including method development and qualification / validation, method transfer, and characterization testing. Conduct the review of analytical raw data packages. Ensure that studies are conducted in compliance with GLP and cGMP regulations, as applicable.
- Resolve technical issues, review deviation events and failure investigations at contractor sites in coordination with internal and external Quality Control, Quality Assurance, and Regulatory groups, as appropriate. Provide technical input for OOS and OOT investigations.
- Collaborate closely with Quality Control and Quality Assurance to ensure the timely GMP release of drug substance and drug product lots.
- Author / review technical documents outlining analytical activities including method validation, method transfer, reference standard and impurity characterization, stability, etc.
- Author / review analytical sections of chemistry, manufacturing and control (CMC) sections of regulatory submissions.
- Represent the analytical function in CMC teams and interdepartmental meetings.
- Maintain current knowledge of issues relevant to drug development, Competent Authority regulations and guidance, as well as industry trends.
- Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
- Act in accordance with Company policies.
- Ability to travel up to 25% domestically and internationally.
- Other duties as assigned.
QUALIFICATIONS :
The base salary range for this role is $172,000 to $229,300 USD ; 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.
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-& long-term disability, accidental death & 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, Learning & 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.
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Salary : $172,000 - $229,300
