Manager, CMC, Quality Control (Stability)

The Timken Company; Vancouver; Hybrid; CAD 84,000 - 118,000; Full time

Job summary

A neuroscience-focused biopharmaceutical company in Vancouver is seeking a Manager, CMC, Quality Control (Stability) to lead stability programs for drug substances and products. The ideal candidate will have over 8 years of experience in the pharmaceutical industry, expertise in ICH guidelines, and strong leadership skills. This hybrid role requires working both in the office and remotely, offering a competitive salary and comprehensive benefits.

Benefits

Medical, dental, and vision insurance

Tuition Assistance program for advanced degrees

Retirement savings program with company matching contributions

Qualifications

• 8+ years of pharmaceutical industry experience in stability functions for small molecules and/or biologics.
• Strong experience using statistical software for trend analysis.
• Demonstrated ability to manage stability programs through various development phases.

Responsibilities

• Lead stability program for drug substances and products across all development phases.
• Collaborate with contract testing laboratories and internal teams.
• Ensure compliance with ICH, FDA, and EMA guidelines.

Skills

Leadership in fast-paced environments

Expertise in ICH stability program design

Trend analysis

Knowledge of quality systems

Education

Bachelor's, Master's, or Ph.D. in a relevant scientific discipline

Tools

Statistical software (e.g., JMP, Minitab)

Stability-specific platforms (e.g., iStability)

Job description

Job Description

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 experienced Manager, CMC, Quality Control (Stability) within the Quality Control team to lead and oversee the design, execution, and management of stability programs for drug substance (DS) and drug product (DP) in accordance with ICH guidelines. The ideal candidate will have a strong background in management of large stability program for small molecules and/or biologics, with experience spanning early clinical development through registration/PPQ and commercial stages. The role involves cross-functional collaboration with Contract Testing Laboratories, Quality Assurance, Regulatory Affairs, Analytical, and DS and DP Manufacturing teams to ensure product quality, compliance, and regulatory readiness.



This position reports to the Director, Quality Control and is a 12-month contract based out of Vancouver, BC, Canada. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate's education and industry experience. This role is a hybrid position, requiring a minimum of 2 days per week in the office.



RESPONSIBILITIES:

• Lead stability program for starting materials, drug substances, and drug products across early development, late-stage clinical, and commercial phases.
• Serve as the QC stability expert on cross-functional teams and in meetings with contract testing laboratories (CTLs).
• Develop and implement phase-appropriate stability testing strategies in alignment with regulatory, clinical, and commercial goals.
• Lead stability protocol design, approval, and execution with contract testing labs, ensuring compliance with ICH, FDA, and EMA guidelines.
• Define stability test attributes, pull schedules, and storage conditions in coordination with internal and external partners.
• Ensure timely drafting of stability summary reports with review and approval at each timepoint, maintaining submission-ready summary reports for regulatory filings.
• Perform stability data trending and shelf-life analysis using statistical tools like JMP or iStability; identify and investigate stability related OOS/OOT results.
• Contribute to CTD Module 2 and 3 stability content for regulatory submissions and support APQR write-up and drive periodic trending reports.
• Provide QC leadership for early and late stage development programs as needed.
• Represent the QC stability function during inspections and internal audits.
• Manage outsourced stability testing to ensure data quality, integrity, and timely delivery.
• Collaborate closely with Analytical, Manufacturing, Supply Chain, and Regulatory teams.
• Communicate stability results, OOTs, and recommendations effectively to internal stakeholders.
• Identify and resolve gaps in the stability and trending programs by updating or creating SOPs to ensure phase-appropriate data management.
• 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.
• Other duties as assigned.

QUALIFICATIONS:

• Bachelor's, Master's, or Ph.D. in a relevant scientific discipline with 8+ years of pharmaceutical industry experience in stability functions for small molecules and/or biologics.
• Demonstrated ability to lead and influence in fast-paced environments, particularly when working with internal teams and contract testing laboratories across multiple time zones.
• Expertise in ICH-guided stability program design, with hands-on experience spanning clinical development phases to commercial stages.
• Working knowledge of ICH Q1A(R2), Q1B, Q1C, Q1D, and Q1E stability guidelines.
• Proficient in trend analysis, regression modeling, and shelf-life estimation in accordance with ICH guidelines.
• Strong experience using statistical software (e.g. JMP or Minitab); familiarity with stability-specific platforms like iStability is a strong asset.
• Skilled in supporting Annual Product Quality Reviews (APQRs) through data compilation, analysis, and report development.
• Experienced with stress condition studies, including forced degradation, photostability, temperature cycling and hold-time studies.
• Proficient in the use of electronic documentation systems, and ensuring data integrity throughout the stability lifecycle.
• Familiar with quality systems, including document control, change management, and cGMP compliance.
• Excellent communication and scientific writing skills, with prior experience in team leadership or project coordination.

The base salary range for this role is $84,400 to $118,000 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.

Qualifications:

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.

As part of our hiring process, Xenon conducts background checks for finalist candidates. The types of checks conducted will vary depending on the relevance to the position.

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.