Associate Director, CMC, Drug Product

Xenon Pharmaceuticals Inc.

Boston (MA)

Hybrid

USD 172,000 - 218,000

Full time

14 days+

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Benefits offered by this job

Base salary

Stock options

Medical

Dental

Vision

Short- & long-term disability

AD&D & life insurance

Employee Assistance Program

Travel insurance

Retirement savings with company match

Job summary

Xenon Pharmaceuticals Inc. is seeking an Associate Director, CMC, Drug Product, to lead early-stage formulation development and preclinical/Phase 1–2 programs from our Boston area offices. The role partners with discovery, QA, and regulatory teams and reports to the Director, CMC, Drug Product.

Hybrid work, based in Needham/Boston with some travel. The candidate will oversee development activities, manage CMOs, and contribute to IND/MAA filings while maintaining cGMP compliance and high-quality

Qualifications

PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Pharmaceutics, or a related discipline with 10+ years pharma/biotech experience (or a BSc/MSc with equivalent experience).
Experience leading early-stage drug product development and managing CMOs.
Strong knowledge of small molecule drug product formulation (capsules, tablets) and regulatory expectations.

Responsibilities

Lead non-clinical formulation and early phase clinical formulation and process development activities for small molecule drug products.
Communicate with cross-functional teams to support CMC decisions across development phases.
Manage early-stage formulation development, drug substance profiling, and developability assessments.
Coordinate clinical trial material manufacturing and packaging with Clinical Supply colleagues.
Oversee selection of early-stage CDMOs, considering capabilities, capacity, and quality.
Provide input for stability programs and packaging selections in collaboration with Analytical teams.
Draft and review core CMC documents and regulatory submissions for IND/NDA/MAA filings.
Ensure documentation quality for batch records, specs, and development reports.

Skills

Leadership

Cross-functional collaboration

Regulatory submissions

Project management

Communication skills

Education

PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Pharmaceutics, or related field

BSc or MSc with relevant experience

Job description

Who We Are

Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.

Who We Are

What We Do

We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy, depression and pain. Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. In March 2026, we announced positive topline data from our Phase 3 X-TOLE2 study of azetukalner in focal onset seizures (FOS), and we anticipate submitting a New Drug Application to the Food and Drug Administration in the third quarter of 2026. Our Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication. We also have multiple Phase 3 azetukalner clinical trials underway in major depressive disorder (MDD) and bipolar depression (BPD), based on topline data from our Phase 2 X-NOVA clinical trial. In addition, we are proud of our strong heritage in human genetics, deep understanding of ion channel biology, and expertise in novel chemistries to enable potent, selective ion channel targeting. We continue to advance an early-stage pipeline of novel therapeutic candidates, including Phase 1 studies for XEN1701 and XEN1720 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are being developed for pain. 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, CMC, Drug Product, to join our team. The Associate Director, CMC, Drug Product will manage and oversee the early-stage assessment and formulation development of drug products pre-clinical and early-stage Phase 1 and 2 clinical programs. The candidate will be a key member of highly collaborative internal Drug Product and CMC teams, primarily managing discovery and toxicology formulation, developability evaluation of candidate molecules, and Phase 1 and 2 formulation and manufacturing process development.

This position reports to the Director, CMC, Drug Product and will be based out of our Boston, MA, USA in our Needham office. We may consider other jurisdictions for exceptional candidates. This role is a hybrid position, requiring a minimum of 2 days per week in the office.

Lead non-clinical formulation and early phase clinical formulation and process development activities of small molecule drug products. Effectively communicate with cross-functional teams to ensure CMC decisions support current and upcoming phases of drug development.
Manage activities related to early-stage formulation development including drug substance attribute profiling, developability assessments and executing plans for first in human phase 1 and phase 2 formulation development. Provide updates to product development teams and program manager as required.
Manage and coordinate clinical trial material manufacturing and packaging for early-stage small molecule assets with assigned Clinical Supply colleagues.
Manage the selection of early-stage CDMOs while considering capabilities, capacities, redundancy and quality. Partner with QA GMP colleagues as required.
Provide input for drug product stability programs and help select appropriate packaging for clinical development in collaboration with Analytical colleagues.
Evaluate, recommend, and manage qualified CROs and CDMOs for manufacturing drug products for discovery, non-clinical and toxicology formulations as well as for early phase clinical trials. Collaborate with Quality Assurance to manage audits and inspections of CDMOs and on manufacturing investigations.
Author and review core CMC documents/modules and other submissions and responses to FDA and other Competent Authorities, ensuring strategic oversight and consistency for regulatory interactions, including IND/NDA/MAA/IMPD filings and periodic updates.
Write, review and/or approve relevant documentation required to support drug development including batch records, specifications, development reports, development protocols and other necessary documentation.
Stay informed on discovery and non-clinical formulation development, pharmaceutical development and manufacturing industry science, regulatory guidelines and competitive trends to provide informed recommendations.
Collaborate with discovery, early and late development partnerships, including ex-US collaborations, to ensure global alignment and integration of strategies.
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

PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Pharmaceutics, or a related discipline with at least 10+ years of relevant experience in a pharma or biotech environment. Candidates with a BSc or MSc and relevant experience will also be considered.
Experience in managing early-stage drug product development and manufacturing activities (first in human and proof of concept formulations), including oversight of external Contract Manufacturing Organizations (CMOs).
Strong background in powder based small molecule drug product development with experience on capsules, tablets, spray drying, granulation, blending, bottling and blistering.
Experience developing solutions, suspensions, granules or powders for suspension, chewable tablets, buccal/sublingual tablets is a plus.
Experience with PK exposure modeling and drug developability is a plus.
Experience supporting discovery, non-clinical and toxicology formulation development including parenterals, solutions, suspensions, lipids/SEDDS/SMEDDS, amorphous or salt forms. Experience in developing formulations of small molecule parenteral dosage forms is a plus.
Experience developing and progressing enabled formulations such as spray dried dispersions, hot melt extrusion, lipid softgels, nano-formulations to the clinic is a plus.
Experience contributing and developing CMC sections for regulatory filings (i.e. US and ex-US) is required.
In-depth knowledge of cGMP regulations, guidance, principles, and best practices related to drug product development and manufacture is required.
Experience with CDMO selection, management, contracting, and issue resolution. Experience working with global CDMOs is required.
Excellent oral and written communication, leadership, and interpersonal skills, with the ability to build credibility and trust both inside and outside the company.