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Head of Formulation and Drug Product Development Lead
2 months ago
At AbCellera, we are breaking the barriers of conventional drug development to propel antibody-based medicines from target to clinic. Our team of scientists, engineers, creatives, and business professionals believes that advancing science enhances lives.
We are seeking an experienced Formulation expert to lead our Process Development team and oversee antibody formulation and CMC drug product development activities. As a leader, you will have the opportunity to develop and build our formulation development platform to safely deliver drug products to patients while leveraging cutting-edge technologies.
About Your Role:
- You will be responsible for developing the overall strategy for all aspects of formulation, drug product, and clinical in-use development for therapeutic antibodies.
- You will develop the formulation and drug product team and workflows to deliver appropriate formulations and drug products for AbCellera's pipeline.
- You will support and provide strategic guidance to meet near and long-term clinical demands with a network of CMOs and CDMOs, as needed.
- You will provide a beginning-to-end solution for all aspects of antibody formulation development.
- You will work closely with AbCellerites to develop an innovative approach to CMC development that is closely integrated with our antibody discovery and development workflows.
- You will develop workflows for screening and selecting lead antibody molecules with optimal developability and manufacturing properties.
- You will prepare regulatory documents and communicate with health authorities.
- You will continuously drive improvements to established processes, increasing speed and efficiency while meeting regulatory requirements.
Your Qualifications:
- You have 12-15+ years of industry experience with a PhD in a relevant scientific discipline or equivalent experience with a BSc or MSc degree.
- You have 6+ years of experience building, leading, and developing a cross-functional team.
- You have experience in establishing and running a Formulation Development team for monoclonal antibodies and other protein biologics.
- You have experience establishing phase-appropriate first-in-human formulation development strategies, including stability evaluation, biophysical characterization, and clinical in-use evaluation.
- You have experience overseeing the execution of formulation and drug product development activities at CDMO partner sites.
- You have experience working closely with Quality teams to establish workflows that enable successful documentation, data capture, and data integrity, ensuring compliance with industry standards.
- You have a deep knowledge of global regulatory expectations for the development of protein biologics, including experience supporting INDs, CTAs, and other regulatory filings.
- You have a bias towards innovation over industry standards, are keen to do things differently, and are passionate about building dynamic teams and capabilities that accomplish important goals.
- You are strongly self-motivated and able to identify project needs and follow up with building and implementing solutions.
- You have experience with device development and/or antibody-drug conjugates.
About Us:
AbCellera is a global company that discovers and develops antibody-based medicines that help people live longer, happier, and more productive lives. We prioritize teams and social groups to build community and connections across AbCellera.
Our hiring range for this role is CAD $152,900 - $229,300 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution. You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority.
