Head of Formulation and Drug Product Development Expert

4 weeks ago


Vancouver, British Columbia, Canada AbCellera Full time
About the Role

AbCellera is seeking an experienced Formulation and Drug Product Development expert to lead our Process Development team. As a key member of our Technical Operations team, you will be responsible for building and leading a team of scientists to oversee antibody formulation and CMC drug product development activities.

Key Responsibilities
  • Develop and implement the overall strategy for all aspects of formulation, drug product, and clinical in-use development for therapeutic antibodies
  • Build and lead a high-performing team of scientists to deliver appropriate formulations and drug products for AbCellera's pipeline
  • Collaborate with our Discovery and Clinical Development teams to support the advancement of antibody programs towards the clinic
  • Develop and implement workflows for screening and selecting lead antibody molecules with optimal developability and manufacturing properties
  • Prepare regulatory documents and communicate with health authorities
  • Drive improvements to established processes, increasing speed and efficiency while meeting regulatory requirements
Requirements
  • 12-15+ years of industry experience with a PhD in a relevant scientific discipline
  • 6+ years of experience building, leading, and developing a cross-functional team
  • Experience in establishing and running a Formulation Development team for monoclonal antibodies and other protein biologics
  • Experience in establishing phase-appropriate first-in-human formulation development strategies, including stability evaluation, biophysical characterization, and clinical in-use evaluation
  • Experience in working closely with Quality teams to establish workflows that enable successful documentation, data capture, and data integrity, ensuring compliance with industry standards
  • Deep knowledge of global regulatory expectations for the development of protein biologics, including experience supporting INDs, CTAs, and other regulatory filings
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.

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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