Boston, MA, USA ● Vancouver, BC, Canada
Xenon Pharmaceuticals (NASDAQ:XENE) – a biopharmaceutical company with operations in Vancouver, BC, Canada and Boston, MA, USA – is committed to delivering innovative medicines to provide a brighter future for patients suffering from neurological disorders.
At Xenon, we are advancing an exciting pipeline of neurology-focused therapies
, with a particular emphasis on novel treatments for both adult and pediatric patients with epilepsy. XEN496 is currently being evaluated in the Phase 3 “EPIK” clinical trial in young patients with KCNQ2-DEE, a rare and severe form of childhood epilepsy. Late-stage development plans are also underway for our XEN1101 program, building upon the compelling data from the Phase 2b “X-TOLE” study in adult patients with focal epilepsy. We are also proud of the leading-edge science coming out of our discovery labs, with many early-stage research programs underway. In addition to Xenon’s proprietary programs, we have ongoing collaborations with our valued pharmaceutical partners. With a healthy balance sheet to support our growth plans, we continue to build a fully-integrated, premier neuroscience company with strong discovery, development, and commercial operations.
Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver new medicines for patients in need. Building and maintaining a respectful, collaborative, inclusive, and productive culture is a priority for us. We are looking for great people who thrive in a fast-paced, dynamic work environment to join our team during this transformative time for Xenon.
We are seeking a Senior Manager, CMC Drug Substance to join our CMC team. Reporting to the Senior Director, CMC, the incumbent will be required to work flexibly across a number of small molecule drug development programs with an emphasis on managing outsourced API process development projects and cGMP API manufacturing campaigns.
This position reports to the Senior Director, CMC, and will be located in either the Vancouver, BC, Canada or Boston, MA, USA location; we may consider other locations for an exceptional candidate.
- As the technical and scientific expert for assigned Xenon programs, lead and manage multiple and concurrent CMC drug substance projects at Xenon’s Contract Development and Manufacturing Organizations (CDMOs). These projects may include one or more of:
- API process development, optimization and validation
- Crystallization process development
- cGMP API manufacturing campaigns
- Scale-ups and technology transfer
- As Xenon programs progress through development, lead process scale-up activities in view of forecasted commercial demand
- Collaborate with internal and external chemists and cross-functional teams to research, develop, and test processes, analytical methods and controls
- Recommend and select vendors for relevant drug substance projects
- Attend CDMOs for manufacturing campaigns as person-in-plant to analyze, troubleshoot and improve manufacturing processes and support tech transfers. Some international travel may be required.
- Contribute to the drafting of the CMC drug substance sections of regulatory submissions (e.g., INDs, CTAs, NDAs).
- Collaborate with internal stakeholders, including CMC Drug Product, Process Chemistry, Supply Chain Management, Quality, and Regulatory
- 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.
- PhD in organic or physical organic chemistry.
- 5-10 years experience in the pharmaceutical industry, directly related to API process development and/or cGMP manufacturing of small molecules APIs.
- Experience working, collaborating with, and managing CDMOs.
- Good knowledge of modern API process technologies.
- Good knowledge and understanding of cGMP of small molecule APIs 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 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.