Principal Scientist/Senior Principal Scientist, Process Chemistry
Xenon Pharmaceuticals (NASDAQ:XENE) – a biopharmaceutical company with operations in Vancouver, BC, Canada and Boston, MA, USA – is advancing an exciting pipeline of therapies for neurological disorders, with a particular focus on innovative treatments for epilepsy. Xenon has a number of promising therapeutics in clinical development, valuable collaborations with pharmaceutical partners, and innovative early-stage research underway and also has a strong balance sheet to support its continued growth in 2021 and beyond.
We are a collaborative, ambitious, and driven team with a common mission to improve the lives of patients with neurological disorders. Creating a healthy and productive work environment is a priority, and we understand the importance of investing in our employees’ growth and development. We support charities and volunteerism, knowing that when our people contribute to their local communities, they are gaining new experiences and becoming even better leaders. Xenon’s employees are smart, passionate, and driven by their incredibly important work to discover, develop and deliver new medicines for patients in need. We are looking for talented and determined individuals who thrive in a fast-paced and dynamic work environment to join our team during this transformative time for the company.
We are seeking an Principal Scientist/Senior Principal Scientist, Process Chemistry to join our team, reporting to the Senior Director, CMC.
This position is designed to transfer synthetic processes from Discovery/Medicinal Chemistry and translate them into streamlined, scalable processes that can ultimately be used at commercial scale. The Principal Scientist/Senior Principal Scientist will then relay this information to a CMC Drug Substance Manager and facilitate the process technology transfer to one of our manufacturing partners. This position also requires the management of a Scientist-level direct report which includes providing a safe work environment, mentoring and performance reviews.
- Manage, in whole and/or in part, the in-house scale-up and drug substance process development of Xenon’s small molecule active pharmaceutical ingredients (APIs). This may include one or more of:
- API process development, route scouting and process optimization
- Crystallization process development
- API manufacturing campaigns in support of GLP studies and exploratory non-GLP toxicology studies
- Working with internal analytical colleagues on possible in-process controls and release methods for Drug Substance
- Synthesis of impurity markers, metabolites, standards (including stable isotope-labeled standards) and other possible one-off synthesis projects.
- Collaborate with colleagues in Discovery to transfer product candidates into the CMC group.
- Collaborate with CMC colleagues managing drug product development to ensure API deliverables are optimal for use in clinical trial materials and/or final Drug Products, such as salt forms and polymorphs.
- Collaborate with other functions as needed on API matters, for example, Intellectual Property, Regulatory and Quality.
- Participate in technology transfers to Xenon’s CDMOs and perform CDMO site visits as required.
- International travel may be required.
- Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices.
- 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.
- PhD degree in synthetic organic/physical organic chemistry.
- A minimum of 8 years’ experience in the pharmaceutical/biotechnology industry, directly related to small-molecule API process development and scale-up.
- Track record of synthetic problem solving and scientific creativity.
- Good knowledge of modern API process technologies.
- Good knowledge and understanding of cGMP and of the US, Canadian and EU regulatory environments; previous experience with IND and CTA CMC submissions preferred.
- 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 accurate, high quality work and reports.
- 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.
- Ability to travel internationally on occasion.