At Arbutus we have a vision: to cure chronic Hepatitis B virus (HBV). We have a dedicated and innovative team and we are uniquely positioned to transform the HBV treatment landscape. We are developing a portfolio of drug candidates with multiple mechanisms of action that we believe will result in a combination therapy to cure HBV.
If you are looking to join a team with a proven track record in drug discovery and development, and are as passionate as we are, we want to hear from you.
Reporting to the Sr. Director, Quality, the Principal Scientist, Analytical Development will be responsible for managing analytical method development, technology transfers, and related CMC activities in collaboration with internal/external resources and external testing labs/product manufacturers to advance products in Arbutus’ diverse pipeline in line with corporate and project objectives.
Duties and responsibilities:
• Manage in-house method development/optimization activities and where appropriate, carry out hands on lab work in support of research and development projects
• Support in-house pre-formulation and formulation studies
• Work closely with CROs/CMOs to transfer/establish and validate methods for raw materials, intermediates, API and drug product that meet industry standards and regulatory requirements, providing technical support as needed
• Propose and conduct product characterization studies and troubleshooting studies in collaboration with internal and external resources, critically evaluate data while drawing appropriate conclusions and develop a forward plan of action
• Critically review, analyse and trend analytical data generated in-house and by external vendors and apply statistical analyses where appropriate
• Recommend and justify purchase of analytical equipment to upgrade internal capabilities in support of on-going development programs
• Write development reports and regulatory submission sections
• Other responsibilities as assigned
• PhD in a related discipline, with a minimum of 10 years’ industry experience, or an equivalent combination of education and experience.
• Progressive experience in the pharmaceutical industry required; experience working in a fast paced biotech environment preferred.
• A proven track record of problem solving, analytical method development and product characterization.
• Significant experience with HPLC analysis and method development.
• Significant experience with HPLC-MS, including identification of impurities.
• Knowledge of statistical analysis, including data trending.
• Experience leading technology transfers to external vendors and on-going management of these external collaborations.
• Excellent verbal and written communication skills; experience with development report generation and authoring of regulatory submissions.
• Knowledge of ICH Guidelines and related regulatory guidances, cGMP.
• Excellent interpersonal and leadership; proven ability to mentor/manage other scientific staff in a matrix environment.
• Proven track record of building and maintaining strong relationships with internal and external stakeholders.
• Ability to manage deadlines and prioritize effectively, while maintaining flexibility.
• Ability to work independently with minimal supervision, take initiative and take on responsibility for projects.