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Senior Manager, CMC, Quality Control Specialist
2 months ago
About Us:
Xenon Pharmaceuticals is a leading biopharmaceutical company dedicated to developing innovative therapeutics for neurological and psychiatric disorders. We are a dynamic and collaborative organization that values expertise, creativity, and teamwork.
Our Mission:
We are committed to advancing cutting-edge treatments that improve the lives of people affected by neurological and psychiatric conditions. Our team is passionate about delivering high-quality products and services that meet the highest standards of excellence.
The Role:
We are seeking a highly skilled Senior Manager, CMC, Quality Control Specialist to join our team. As a key member of our CMC Quality Assurance team, you will be responsible for ensuring the quality and integrity of our products throughout the development and manufacturing process.
Key Responsibilities:
- Develop and Maintain Master Specifications: Create and maintain master specifications for starting materials, reference standards, API, and drug products for assigned clinical/commercial programs.
- Stability Program Management: Manage stability studies for reference standards, API, and drug products, including compiling stability protocols and monitoring all stability data.
- Method Validations and Investigations: Manage the review and approval workflow for feasibility/comparability studies, validation protocols, reports, and test methods with internal experts and external partners.
- Reference Standard Program Management: Lead the reference standard program for assigned clinical/commercial programs at dedicated external labs, including qualification and distribution of reference standards to all manufacturing & testing facilities.
- Quality Control and Assurance: Lead investigations and draft 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.
- Regulatory Submissions: Draft, review, and perform quality control checks on the CMC sections of regulatory submissions (e.g., INDs, CTAs, and NDAs).
- Quality Functions and Compliance: Engage in and ensure compliance with appropriate quality functions, including deviations, change controls, and CAPAs.
- Release and Stability Management: 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.
- External Laboratory Management: Ensure effective working relationships with external labs and CMOs, participate in remote audits, and perform on-site audits as required.
- Quality Control Data Management: 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.
- Collaboration and Communication: 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.
- Technical Expertise: 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.
- Leadership and Development: 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.
Requirements:
- Education and Experience: Bachelor's or Master's degree with 8 years of experience in the pharmaceutical industry (small molecule and/or biologics).
- Quality Control and Assurance: 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.
- Leadership and Collaboration: 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.
- Communication and Teamwork: Excellent oral and written communication skills and previous team leadership experience.
Compensation and Benefits:
The base salary range for this role is $125,400 to $149,600 CAD; we will consider above this range for exceptional candidates. 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.
Accoravillage Culture:
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.
