Director/Senior Director, Drug Product, Chemistry, Manufacturing and Controls
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 a Director/Senior Director, Drug Product CMC to join our team. The Director/Senior Director, Drug Product CMC (Chemistry, Manufacturing and Controls) manages and oversees the development and manufacturing of cGMP drug products for deployment in early- and late-stage clinical trials and commercial distribution. The Director/Senior Director will be a key member of a highly collaborative internal CMC team, primarily managing programs and manufacturing campaigns through CDMOs and CROs. This is a hands-on role with direct reports.
The Director/Senior Director will have proven leadership ability in a fast paced, multi-location environment and will have a strong track record of productive interactions with all levels of internal staff as well as external stakeholders, including, but not limited to, consultants, CDMOs and CROs.
This position reports to the Vice President, Product Development and Operations, and will be located in either the Vancouver, BC, Canada or Boston, MA, USA metropolitan areas; we may consider other locations for an exceptional candidate.
- Manage and oversee the development and manufacturing of small molecule drug products in accordance with applicable quality and regulatory standards.
- Manage formulation, process research and development activities, and, as appropriate, technology transfer, through CDMOs including process validation and the establishment of suitable specifications for excipients and finished drug products; provide input into analytical method development.
- Provide input for drug product stability programs and evaluate and select drug product packaging, as suitable, for clinical development and commercial purposes.
- Evaluate, recommend and manage qualified CDMOs for the manufacture of drug products for clinical trials, scale up, validation and commercial use; in conjunction with Quality Assurance, manage and oversee audits and inspections of CDMOs.
- Author and/or act as a key reviewer of core CMC documents/modules and other forms of submissions and responses to FDA and other Competent Authorities providing strategic oversight and consistency for regulatory interactions, including, but not limited to, IND/NDA/MAA/IMPD filings and periodic updates thereto.
- Maintain current knowledge of issues relevant to pharmaceutical development, drug development, Competent Authority regulations and guidance, as well as competitive trends to inform input and recommendations.
- Plan and manage drug product-related budget proposals and approved project budgets in accordance with the Company’s strategic and operating plans and Finance policies.
- Recruit, lead, direct, develop, coach and evaluate direct reports 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, if any.
- PhD in Chemistry, Pharmaceutical Sciences, Pharmaceutics or other relevant discipline with a minimum of 10 years of directly-related experience in a pharma or biotech environment. Candidates with a MSc and relevant experience may be considered.
- Deep and broad experience in managing development-stage and commercial-stage drug product manufacturing activities for solid oral dosage forms and ideally in the development of pediatric formulations.
- Experience in acting as strategic lead for key CMC sections in US NDA and European MAA filings, for solid oral dosage forms (adult). Preferably experienced in pediatric applications.
- Extensive knowledge of cGMP-related regulations, guidance, principles and best practices pertinent to drug products.
- Experience with CDMO selection, vendor management, contracting, issue resolution and management
- Excellent oral and written communication, leadership and interpersonal skills as well as the ability to build credibility and trust inside and outside the Company.
- Proven ability to build and develop high performing teams; excellent delegation and conflict resolution skills.
- Be science- and data-driven while at the same time, creative and flexible in strategic thinking and problem solving.
- Ability and willingness to travel up to 15% of the time, both domestically and internationally.
To apply for this position, please click Apply Now to create a candidate profile, and complete the job application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for an interview will be contacted.