Head of Formulation and Drug Product Development

About AbCellera

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.

How you might spend your days

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

Developing workflows for screening and selecting lead antibody molecules with optimal developability and manufacturing properties

Preparing regulatory documents and communicating with health authorities

Continuously driving improvements to the established processes, increasing speed and efficiency while meeting regulatory requirements

We'd love to hear from you if

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

What we offer

AbCellera's 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, opportunity for flexible work arrangements, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you'll find we prioritize teams and social groups to build community and connections across AbCellera.

About 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.

And it all starts with our team. We've built a place where people feel they are part of something bigger than themselves. A place that exists to push the limits of science and technology, and aims to bring better therapies to patients.

We look for people with drive and energy. Idealists. People we love and people we trust. This may be unconventional, but it is the key to our success.

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