Head of Formulation and Drug Product Development Full-time Vancouver, British Columbia, Canada Apply now April 15, 2024 Job ID: 23200 AbCellera is breaking the barriers of conventional drug development to propel antibody-based medicines from target to clinic. We are a team of scientists, engineers, creatives, and business professionals who believe that advancing science enhances lives. We have developed technologies to unlock high-value drug targets, including antibody-drug conjugates and T-cell engagers for cancer, and complex transmembrane proteins for indications such as metabolic and endocrine conditions, pain, and autoimmunity. We are looking for a Head of Formulation and Drug Product Development who will be responsible for building and leading a team of scientists to oversee antibody formulation and CMC drug product development activities. As a leader in our Process Development team, you will have the opportunity to further develop and build our formulation development platform to safely deliver drug products to patients, all while leveraging cutting edge technologies. In this role, based in beautiful Vancouver, Canada, you will work closely with our Technical Operations, Discovery and Clinical Development teams to support the advancement of antibody programs towards the clinic. Further developing the overall strategy for all aspects of formulation, drug product, and clinical in-use development for therapeutic antibodies Developing the formulation and drug product team and workflows to deliver appropriate formulations and drug products for AbCellera's pipeline Supporting and providing strategic guidance to meet near and long term clinical demands with a network of CMOs and CDMOs, as needed Providing a beginning-to-end solution for all aspects of antibody formulation development Working closely with AbCellerites to develop an innovative approach to CMC development that is closely integrated with our antibody discovery and development workflows Preparing regulatory documents and communicating with health authorities Continuously driving improvements to the established processes, increasing speed and efficiency while meeting regulatory requirements You have 12-15+ years of industry experience with a PhD in a relevant scientific discipline. Strong candidates with BSc or MSc degrees may be considered with sufficient Process Development and leadership experience 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 in 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. Direct experience interacting with regulatory agencies and health authorities is desired 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 are able to identify project needs and follow that up with building and implementing solutions You have experience with device development and/or antibody-drug conjugates AbCellera's hiring range for this role is $152,900 - $229,300 CAD annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, an annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution. You will have a $1,500 annual Active Lifestyle Allowance, annual vacation, the opportunity for flexible work arrangements, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you'll find abundant teams and social groups to build community and connections across AbCellera. AbCellera is a global company that discovers and develops antibody-based medicines that help people live longer, happier, and more productive lives. We are focused on bringing innovative medicines to patients, both by advancing our internal pipeline of programs and partnering with companies that have novel science or innovative technology.