Head of Formulation and Drug Product Development Expert

2 days ago


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

AbCellera is seeking an experienced Formulation and Drug Product Development professional to lead our team in developing innovative antibody-based medicines. As Head of Formulation and Drug Product Development, 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 team of scientists to deliver appropriate formulations and drug products for AbCellera's pipeline
  • Support and provide strategic guidance to meet near and long-term clinical demands with a network of CMOs and CDMOs, as needed
  • Develop workflows for screening and selecting lead antibody molecules with optimal developability and manufacturing properties
  • Prepare regulatory documents and communicate with health authorities
  • Continuously 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. Strong candidates with BSc or MSc degrees may be considered with sufficient Process Development and leadership experience
  • 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 establishing phase-appropriate first-in-human formulation development strategies, including stability evaluation, biophysical characterization, and clinical in-use evaluation
  • Experience overseeing the execution of formulation and drug product development activities at CDMO partner sites
  • 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. Direct experience interacting with regulatory agencies and health authorities is desired
  • Bias towards innovation over industry standards, keen to do things differently, and passionate about building dynamic teams and capabilities that accomplish important goals
  • Strongly self-motivated and able to identify project needs and follow that up with building and implementing solutions
  • 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, 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.



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