Research Scientist 2, CMC, Analytical Chemistry

We are seeking a Research Scientist 2, CMC, Analytical Chemistry to join our CMC team. The ideal candidate will work flexibly across a number of small molecule drug development programs with an emphasis on the development of in-house analytical methods on new research/development compounds that will be subsequently transferred to external cGMP testing labs. The preformulation studies (polymorphism, solubility assessment, material characterization etc.) will be a secondary aspect to the role which will be used to support the Company’s ongoing discovery and development programs.

This position reports to the Principal Scientist, Analytical Chemistry and will be in the Vancouver, BC, Canada location. The level of the position will be commensurate with the candidate’s education and industry experience. This is a permanent, full-time position.

RESPONSIBILITIES:

• Develop, pre-validate, and troubleshoot analytical methods for starting materials, process intermediates, drug substances, and drug products from Xenon’s internal pipeline. Assess current analytical methods and optimize where applicable.
• Design and execute dissolution experiments. Develop dissolution methods for solid oral dosage forms.
• Support method qualification/validation studies by designing and/or reviewing validation protocols, reports and raw data as needed.
• Closely collaborate with Drug Substance and Drug Product during development
• Collaborate with colleagues in the Discovery group to evaluate and transfer product candidates into the CMC group. Conduct preformulation studies to enable formulation development.
• Identify impurities in the drug substance or drug product.
• Perform excipient compatibility and stability studies to aid with formulation selection.
• Transfer methods to our outsourced contract organizations in collaboration with QC.
• Independently design and conduct analytical experiments.
• Implement new experimental protocols and techniques.
• Interpret results and draw conclusions from experiments; design and pursue relevant experiments.
• Evaluate data and summarize in associated reports and documentation.
• Understand relevant scientific literature and apply theoretical framework to solving problems.
• Interact with cross-functional teams with internal and external team members from various functional departments including Drug Substance, Drug Product, Quality Control, Quality Assurance, and Regulatory.
• General laboratory maintenance and monitoring.
• Maintain analytical equipment within the analytical laboratory.
• Write standard operating procedures and/or standard testing procedures as required. Develop in-house technical documents for the qualification, use and maintenance of analytical equipment in the CMC group
• Organize and file internal data, protocols, and reports.
• Effective time management with an emphasis on prioritizing projects as needed.
• 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.
• Ensure the laboratory environment is safe and well-organized; follow and keep up to date with Health & Safety policies.  
• 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:

• An MSc or PhD in analytical/physical/organic chemistry, or pharmaceutical sciences is required.
• A minimum of 5 years experience for MSc (or 2 years for PhD) in the pharmaceutical industry, directly related to analytical  development on small molecule drug substances and drug products is required.
• Extensive experience with chromatographic techniques (HPLC, GC), including assay and related substance method development, forced degradation studies, and excipient compatibilities studies.
• Hands-on experience developing dissolution methods for solid oral dosage forms is required.
• Impurity identification experience using LCMS and GCMS mass spectra is highly preferred.
• Relevant experience in the field of preformulation, solid state chemistry would be a plus.
• Excellent written and oral communication skills, including the ability to communicate with scientific and non-scientific personnel.
• Excellent attention to detail and commitment to providing reliable, accurate, high-quality data.
• Self-motivated with 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.
• Language of work is English.

The base salary range for this role is $96,000 to $121,400 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.