Associate Director, CMC, Drug Substance

Xenon Pharmaceuticals Inc.

. Manage and oversee development and manufacturing of cGMP small molecule APIs for pre-pivotal and pivotal clinical trials .

Posted 9/23/2026full-timeBoston • Massachusetts • United StatesSenior💰 $172,300 - $217,900 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Expertise in managing cGMP small molecule API development and manufacturing for clinical trials, with a strong focus on regulatory submissions and quality assurance. Proven ability to lead cross-functional teams and manage vendor relationships in a dynamic pharmaceutical environment.

Highest-signal resume keywords

PhD In ChemistryCGMP Regulations KnowledgeAPI Manufacturing ManagementIND/NDA/MAA Filings ExperienceVendor Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

API Process Technology TransferClinical Demand ForecastingCMC Document AuthoringRisk-Based Decision-Making ToolsBudget Management

Soft Skills

Excellent Communication SkillsInterpersonal SkillsAttention To DetailOrganizational SkillsTeam Collaboration

Industry Keywords

PharmaBiotechCDMOQuality AssuranceClinical Trials

About the role

Key responsibilities & impact

Manage and oversee development and manufacturing of cGMP small molecule APIs for pre-pivotal and pivotal clinical trials
Evaluate, recommend and manage qualified CDMOs for API manufacture for clinical trials and commercial use
Manage API process technology transfer to CDMOs, including process development and establishment of suitable API specifications
Translate clinical demand forecasts into API manufacturing plans with Supply Chain and CMC Drug Product colleagues
Author or review core CMC documents/modules and submissions and responses to the FDA and other competent authorities
Provide strategic oversight and consistency for IND, NDA, MAA and IMPD filings and periodic updates
Participate in and manage API-related budget proposals and approved project budgets
Serve as subject matter expert in audits and inspections of API CDMOs with Quality Assurance
Ensure Company policies are understood and followed by direct reports
Travel internationally as required
Perform other duties as assigned
Report to the Senior Director, CMC, Drug Substance

Requirements

What you’ll need

PhD in Chemistry or another relevant discipline with a minimum of 10 years of directly related experience in a pharma or biotech environment; candidates with an MSc and significant relevant experience may be considered
Demonstrated track record managing development-stage and/or commercial-stage API manufacturing activities conducted at CDMOs
Experience running initial cGMP deliveries followed by tech transfers to later-stage development CDMOs
Experience authoring/co-authoring key CMC sections in U.S. IND/NDA and European MAA filings for small molecule APIs
Extensive knowledge of cGMP-related regulations, guidance documents, principles, and best practices pertinent to APIs
Strong experience in a virtual manufacturing setting, including CDMO landscape and selection, vendor management, contracting, issue resolution and management
Excellent written and oral communication skills
Experience applying risk-based decision-making tools
Excellent interpersonal skills and ability to build credibility and trust inside and outside the Company
Excellent attention to detail and commitment to accurate, high-quality work
Good organizational skills and ability to manage multiple competing priorities
Strong interpersonal and team skills to work independently and collaboratively as part of a multidisciplinary team
Science- and data-driven approach with creative and flexible strategic thinking and problem solving
Ability and willingness to travel up to 15% of the time, domestically and internationally

Benefits

Comp & perks

Base salary
Target bonus
Stock options/equity
Medical insurance
Dental insurance
Vision insurance
Short-term disability insurance
Long-term disability insurance
Accidental death & dismemberment insurance
Life insurance
Employee Assistance Program
Travel insurance
Retirement savings programs with company matching contributions
Vacation days
Personal days
Sick days
End-of-year company shutdown
Training, Learning & Development program
Tuition Assistance program for advanced degrees
Hybrid work arrangement