Principal Scientist, CMC, Drug Product
4 weeks ago
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 a Principal Scientist, CMC, Drug Product (Pre-Formulation) to join our team. The candidate will be responsible for leading the development of suitable formulations for the in vivo assessment (including for GLP toxicology studies) of novel chemical compounds originating from our Discovery team. Additionally, the incumbent will support the physicochemical characterization of compounds that are deemed to be of interest for further downstream clinical development. This is a hands-on, laboratory-based position which includes managing a small team.
This position reports to the Director, CMC, Drug Product and will be in Vancouver, BC, Canada. The level of the position will be commensurate with the candidate's education and industry experience.
RESPONSIBILITIES:
1. In collaboration with the Discovery and Toxicology teams, lead the development of suitable preclinical formulations for the in vivo assessment of compounds of interest.
2. Working closely with CMC Analytical Development, ensure that adequate preformulation/characterization data (e.g., XRPD, DSC, PSD) for compounds of interest are available to enable formulation decisions.
3. Collaborate with other colleagues within the CMC Department (e.g., process chemistry, CMC Drug Substance, CMC Drug Product).
4. Author formulation development reports in support of regulatory and business activities.
5. Organize and file internal data, protocols and reports.
6. Effectively engage external resources (e.g., CROs) as required to facilitate the development of preclinical formulations.
7. Keep up to date and detailed records of experiments and data analysis within an Electronic Lab Notebook system. Ensure experiments are counter-signed on a monthly basis.
8. Adhere to and promote Xenon's lab safety requirements.
9. Ensure the laboratory environment is safe and well-organized; follow and keep up to date with Health & Safety policies.
10. Recruit, lead, direct, develop, coach, and evaluate direct reports, if any, in accordance with the Company's Human Resource policies and practices.
11. 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.
12. Some international travel may be required.
13. Other duties as assigned.
QUALIFICATIONS:
1. PhD in organic/physical organic/analytical chemistry, pharmaceutics, pharmacy or pharmaceutical sciences
2. A minimum of 10+ years' experience in the pharmaceutical industry, directly related to formulation development for small molecules (injectables, orals, intra-peritoneal)
3. Previous experience with particle size reduction techniques such as micronization and developing spray-dried dispersion formulations for preclinical evaluation is a plus
4. Prior experience with mentoring, coaching and/or leading a team of junior scientists
5. Excellent written and oral communication skills, including the ability to communicate effectively with scientific and non-scientific personnel
6. Excellent attention to detail and commitment to providing accurate, high-quality work
7. Good organizational skills and the ability to manage multiple competing priorities
8. 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 $150,500 to $191,700 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.
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.
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