Senior Manager, CMC, Quality Control

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 a Senior Manager, CMC, Quality Control to join our team. The Senior Manager, CMC, Quality Control will work flexibly across several small molecule drug development programs with an emphasis on managing outsourced testing and stability programs for the cGMP API and drug product (DP) manufacturing and testing campaigns.

This position reports to the Associate Director, CMC, Quality Control and will be in Vancouver, BC, Canada. We will consider other jurisdictions for exceptional candidates.

This role is a hybrid position, requiring a minimum of 2 days per week in the office.

RESPONSIBILITIES :

• Develop and maintain master specifications for starting materials, reference standards, API, and drug products for assigned clinical / commercial program(s).
• Manage stability studies for reference standards, API, and drug products. Compile stability protocols and monitor all stability data, including shelf life trending and extensions.
• Manage the review and approval workflow for feasibility / comparability studies, validation protocols, reports, and test methods with internal experts and external partners.
• Lead the reference standard program for the assigned clinical / commercial program at dedicated external labs, including qualification and distribution of reference standards to all manufacturing & testing facilities.
• Lead investigations and draft the reports for out-of-specification (OOS) and out-of-trend (OOT) results during release and stability testing in close collaboration with internal teams and external testing labs.
• Draft, review, and perform quality control checks on the CMC sections of regulatory submissions (e.g., Investigational New Drugs (INDs), Clinical Trial Applications (CTAs), and New Drug Applications (NDAs).
• Engage in and ensure compliance with appropriate quality functions, including deviations, change controls, and CAPAs.
• Compile and manage internal release documents for drug substances, drug products, and reference standards, including Certificate of Analysis and Certificate of Testing in collaboration with quality assurance.
• Ensure effective working relationships with external labs and CMOs, participate in remote audits, and perform on-site audits as required.
• Review, manage and compile all analytical / non-analytical results for product release, and stability, including, OOS and OOT observations.

Organize and file internal and external quality control data, protocols, and reports.

• Effectively collaborate with colleagues in Drug Product, API groups, Supply Chain, QA, and Regulatory Affairs to ensure that deliverables are optimal for use in clinical trial material.
• Provide sound technical knowledge of quality control to support the transfer of new drug candidates from research / discovery groups to the CMC drug development team.
• Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans.
• Recruit, lead, direct, develop, coach and evaluate direct reports, if any, 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, if any.
• Some international travel may be required.
• Other duties as assigned.

QUALIFICATIONS :

• Bachelor's or Master's degree with 8 years of experience in the pharmaceutical industry (small molecule and / or biologics).
• Strong experience with quality control testing, stability program management by ICH guidelines, master specifications, method validations, investigations (OOS / OOT), batch release processes, and quality management systems is required.
• Be able to manage external testing laboratories independently and influence in a fast-paced environment while exhibiting a strong quality mindset.
• Prior experience with IND, BLA, and / or CTA CMC submissions is preferred; knowledge of cGMP and the US, Canadian, and EU regulatory environments.
• Experience auditing external laboratories, FDA / EMA inspections, and inspection readiness is preferred.
• Collaboration and inclusion between external testing labs and cross-functional CMC teams are essential.
• Excellent oral and written communication skills and previous team leadership experience.

The base salary range for this role is $125,400 to $149,600 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.

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.

US positions only : Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here.

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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