Genevant is a technology-focused nucleic acid delivery company with world-class platforms, the industry’s most robust and expansive lipid nanoparticle (LNP) patent estate, and decades of experience and expertise in nucleic acid drug delivery and development. Our laboratories and offices are based in beautiful Vancouver, British Columbia.
Role Summary:
Genevant has an opportunity for a highly motivated and skilled individual to join our team as the Director of Analytical Development & Quality Control. Reporting to the VP, Pharmaceutical Development, the Director of AD/QC will be responsible mentoring reporting staff, providing technical and strategic leadership to the AD/QC function, and for managing vendors in support of partnered drug development programs.
Core Duties and responsibilities:
Direct in-house analytical method development activities for lipid excipients, nucleic acid APIs and LNP drug products. Provide sound technical knowledge in quality control and analytical chemistry in support of group, departmental and cross functional objectives
Participate as the Analytical Development & Quality Control subject matter expert in cross-functional project teams for external partner collaborations
Work closely with CROs/CMOs to transfer/establish and validate analytical methods for raw materials, in-process tests, API’s and finished products that meet industry standards and regulatory requirements, providing technical support as needed
Design and oversee external method qualification/validation studies. Review protocols, reports and data and secure internal approval
Manage vendors to perform release testing of raw materials and finished product. Review QC results and reports for product release and disposition, including investigations and resolution of deviations, OOS, and OOT observations
Work closely with Manufacturing, Regulatory and QA to develop specifications for critical or custom raw materials, APIs and drug products that meet industry standards and regulatory requirements for phase of development
Propose and conduct product characterization studies in collaboration with internal and external resources, critically evaluate data while drawing appropriate conclusions and develop a forward plan of action
Manage stability programs and critically review, analyse and trend analytical data generated in-house and by external vendors and apply statistical analyses where appropriate
Manage the reference standard inventory for all programs including procurement, qualification, and distribution to internal and external test sites
Recommend and justify purchase of analytical equipment to upgrade internal capabilities in support of on-going development programs
Compiling and authoring QC and CMC analytical related reports and analytical sections of regulatory submissions ensuring compliance with applicable regulatory guidelines
Foster a spirit of cooperation, teamwork and motivation within the department
Qualifications:
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.
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 analytical sections of regulatory submissions.
Excellent interpersonal, leadership and management skills.
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.
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