Associate Director, CMC, Drug Product

Company: Xenon
Location: Boston
Posted on: April 3, 2025

Job Description:

Posted Thursday, March 27, 2025 at 10:00 AMWho 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 Associate Director, CMC, Drug Product to join our CMC team. The incumbent will be required to work flexibly across a number of small molecule drug development programs with an emphasis on managing outsourced Drug Product development activities and cGMP Drug Product manufacturing campaigns.This position reports to the Director, CMC, Drug Product and will be in Boston, MA, USA location. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate's education and industry experience.RESPONSIBILITIES:

• As the technical and scientific expert for assigned Xenon programs, lead and manage multiple and concurrent CMC drug product projects at Xenon's Contract Development and Manufacturing Organizations (CDMOs). These projects may include one or more of:
  • Drug Product formulation development, process development, optimization, and validation
  • cGMP drug product manufacturing campaigns
  • Scale-ups and technology transfer
  • Lead process scale-up activities in view of forecasted commercial demand as Xenon programs progress through development.
  • Collaborate with internal and external scientists and cross-functional teams to research, develop, and test processes, analytical methods, and controls.
  • Attend development and manufacturing activities at CDMOs to analyze, troubleshoot, and improve manufacturing processes and support tech transfers.
  • Contribute to the drafting of the CMC drug product sections of regulatory submissions (e.g., INDs, IMPDs, CTAs, NDAs).
  • Collaborate with internal stakeholders, including CMC Drug Substance, Supply Chain Management, Quality, and Regulatory Affairs.
  • 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, Pharmaceutical Sciences, or Chemical Engineering. Candidates with an MSc and significant relevant experience may be considered as well.
    • A minimum of 8 years' experience in the pharmaceutical industry, directly related to drug product formulation development, process development, and cGMP manufacturing of solid oral dosage forms.
    • Experience working, collaborating with, and managing CDMOs.
    • Good knowledge of modern technologies for solid oral dosage forms.
    • Good knowledge and understanding of cGMP of drug product manufacturing and of the US, Canadian, and EU regulatory environments; previous experience with IND, IMPD, and NDA submissions preferred.
    • Excellent written and oral communication skills, including experience in technical writing in support of regulatory submissions.
    • Excellent attention to detail and commitment to providing accurate, high-quality work.
    • Good organizational skills and the ability to manage multiple competing priorities.
    • Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team.The base salary range for this role is $164,300 to $207,800 USD; 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.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.
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Keywords: Xenon, Boston , Associate Director, CMC, Drug Product, Executive , Boston, Massachusetts